ICS 23.020.

30 Edition February 1998

Pressure Equipment Directive

Content
Pressure Equipment Directive
Annex I Essential safety requirements
Annex II Conformity assessment tables
Annex III Conformity assessment procedures
Annex IV Minimum criteria to be met when designating the notified
bodies referred to in Article 12 and the recognized third-
party organisations referred to in Article 13
Annex V Criteria to be met when authorizing user
inspectorates referred to in Article 14
Annex VI CE marking
Annex VII Declaration of conformity

_______________

DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 29 May 1997
on the approximation of the laws of the Member States concerning pressure equipment

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF
THE EUROPEAN UNION –
Having regard to the Treaty establishing the European Com-
munity, and in particular Article 100a thereof,
Having regard to the proposals from the Commission 1),
Having regard to the Opinion of the Economic and Social
Committee 2),
Acting in accordance with the procedure laid down in
Article 189b of the Treaty 3), in the light of the joint text ap-
proved by the Conciliation Committee on 4 February 1997,
(1) Whereas the internal market is an area without internal
frontiers in which the free movement of goods, persons,
services and capital is ensured;
(2) Whereas there are differences in the content and
scope of the laws, regulations and administrative provisions
in force in the Member States with regard to the safety and
protection of health of persons and, where appropriate, do-
mestic animals or property, where pressure equipment not
covered by present Community legislation is concerned;
whereas the certification and inspection procedures for such
equipment differ from one Member State to another; where-
as such disparities may well constitute barriers to trade
within the Community;
(3) Whereas the harmonization of national legislation is
the only means of removing these barriers to free trade;
1)
OJ No C 246, 9. 9. 1993, p. 1 and OJ No C 207, 27. 7. 1994, p. 5.
2)
OJ No C 52, 19. 2. 1994, p. 10.
3)
Opinion of the European Parliament of 19 April 1994 (OJ No C 128,
9. 5. 1994, p. 61), common position of the Council of 29 March 1996
(OJ No C 147, 21. 5. 1996, p. 1), Decision of the European Parlia-
ment of 17 July 1996 (OJ No C 261, 9. 9. 1996, p. 68). Council Deci-
sion of 17 April 1997.
whereas this objective cannot be achieved satisfactorily by
the individual Member States; whereas this Directive only
lays down indispensable requirements for the free circula-
tion of the equipment to which it is applicable;
(4) Whereas equipment subject to a pressure of not more
than 0,5 bar does not pose a significant hazard due to pres-
sure; whereas there should not therefore be any obstacle to
its free movement within the Community; whereas this
Directive applies to equipment subject to a maximum
allowable pressure PS exceeding 0,5 bar;
(5) Whereas this Directive relates also to assemblies com-
posed of several pieces of pressure equipment assembled
to constitute an integrated and functional whole; whereas
these assemblies may range from simple assemblies such
as pressure cookers to complex assemblies such as water-
tube boilers; whereas, if the manufacturer of an assembly in-
tends it to be placed on the market and put into service as
an assembly – and not in the form of its constituent non-
assembled elements – that assembly must conform to this
Directive; whereas, on the other hand, this Directive does
not cover the assembly of pressure equipment on the site
and under the responsibility of the user, as in the case of in-
dustrial installations;
(6) Whereas this Directive harmonizes national provisions
on hazards due to pressure; whereas the other hazards
which this equipment may present accordingly may fall
within the scope of other Directives dealing with such haz-
ards; whereas, however, pressure equipment may be in-
cluded among products covered by other Directives based
on Article 100a of the Treaty; whereas the provisions laid
down in some of those Directives deal with the hazard due
to pressure; whereas those provisions are considered ade-
quate to provide appropriate protection where the hazard
due to pressure associated with such equipment remains
small; whereas, therefore, there are grounds for excluding
such equipment from the scope of this Directive;
Page 2 PED, 02.1998 edition
(7) Whereas, for pressure equipment covered by interna-
tional Conventions, transport and pressure hazards are due
to be dealt with as soon as possible by forthcoming Commu-
nity Directives based on such Conventions or by supple-
ments to existing Directives; whereas such equipment is
accordingly excluded from the scope of this Directive;
(8) Whereas certain types of pressure equipment, although
subject to a maximum allowable pressure PS higher than
0,5 bar, do not present any significant hazard due to pressure,
and therefore the freedom of movement of such equipment in
the Community should not be hindered if it has been legally
manufactured or placed on the market in a Member State;
whereas it is not necessary in order to ensure free movement
of such equipment to include it in the scope of this Directive;
whereas consequently it is expressly excluded from its scope;
(9) Whereas other pressure equipment subject to a maxi-
mum allowable pressure higher than 0,5 bar and presenting
a significant hazard due to pressure, but in respect of which
free movement and an appropriate level of safety are guar-
anteed, is excluded from the scope of this Directive; where-
as such exclusions should, however, be regularly reviewed
in order to ascertain whether it is necessary to take action at
Union level;
(10) Whereas regulations to remove technical barriers to
trade must follow the new approach provided for in the
Council Resolution of 7 May 1985 on a new approach to
technical harmonization and standards 4), which requires a
definition of the essential requirements regarding safety and
other requirements of society without reducing existing, jus-
tified levels of protection within the Member States; whereas
that Resolution provides that a very large number of prod-
ucts be covered by a single Directive in order to avoid fre-
quent amendments and the proliferation of Directives;
(11) Whereas the existing Community Directives on the ap-
proximation of the laws of the Member States relating to pres-
sure equipment have made positive steps towards removing
barriers to trade in this area; whereas those Directives cover
that sector only to a minor extent; whereas Council Directive
87/404/EEC of 25 June 1987 on the harmonization of the laws
of the Member States relating to simple pressure vessels 5) is
the first case of application of the new approach to the sector
of pressure equipment; whereas the present Directive will not
apply to the area covered by Directive 87/404/EEC; whereas,
no later than three years after the present Directive enters into
force, a review will be carried out of the application of Directive
87/404/EEC in order to ascertain the need for the integration
thereof into the present Directive;
(12) Whereas the framework Directive, Council Directive
76/767/EEC of 27 July 1976 on the approximation of the
laws of the Member States relating to common provisions
for pressure vessels and methods for inspecting them 6) is
optional; whereas it provides for a procedure for the bilateral
recognition of testing and certification of pressure equip-
ment which did not operate satisfactorily and which there-
fore must be replaced by effective Community measures;
(13) Whereas the scope of this Directive must be based on
a general definition of the term “pressure equipment” so as
to allow for the technical development of products;
(14) Whereas compliance with the essential safety re-
quirements is necessary in order to ensure the safety of
pressure equipment; whereas those requirements have
been subdivided into general and specific requirements
4)
OJ No C 136, 4. 6. 1985, p. 1.
5)
OJ No L 220, 8. 8. 1987, p. 48. Directive as last amended by Directive
93/68/EEC (OJ No L 220, 30. 8. 1993, p. 1).
6)
OJ No L 262, 27. 9. 1976, p. 153. Directive as last amended by the
1994 Act of Accession.
which must be met by pressure equipment; whereas in par-
ticular the specific requirements are intended to take ac-
count of particular types of pressure equipment; whereas
certain types of pressure equipment in categories III and IV
must be subject to a final assessment comprising final in-
spection and proof tests;
(15) Whereas Member States should be in a position to al-
low the showing at trade fairs of pressure equipment which
is not yet in conformity with the requirements of this Direc-
tive; whereas, during demonstrations, appropriate safety
measures must be taken in accordance with the general
safety rules of the Member State concerned to ensure the
safety of persons;
(16) Whereas in order to ease the task of demonstrating
compliance with the essential requirements, standards har-
monized at European level are useful, especially with regard
to the design, manufacture and testing of pressure equip-
ment, compliance with which enables a product to be pre-
sumed to meet the said essential requirements; whereas
standards harmonized at European level are drawn up by
private bodies and must retain their non-mandatory status;
whereas, for this purpose, the European Committee for
Standardization (CEN) and the European Committee for
Electrotechnical Standardization (Cenelec) are recognized
as being the bodies that are competent to adopt harmonized
standards that follow the general guidelines for cooperation
between the Commission and those two bodies signed on
13 November 1984;
(17) Whereas, for the purposes of this Directive, a harmo-
nized standard is a technical specification (European stand-
ard or harmonization document) adopted by one or other of
those bodies, or by both, at the request of the Commission
pursuant to Council Directive 83/189/EEC of 28 March 1983
laying down a procedure for the provision of information in
the field of technical standards and regulations 7) and in ac-
cordance with the general guidelines referred to above;
whereas, in relation to standardization, it would be advisable
for the Commission to be assisted by the Committee set up
pursuant to Directive 83/189/EEC; whereas the Committee
will, if necessary, consult technical experts;
(18) Whereas manufacturing of pressure equipment calls
for the utilization of safe materials; whereas in the absence
of harmonized standards it is useful to define the character-
istics of the materials intended for repeated use; whereas
this definition is established by European approvals for ma-
terials, such approvals being issued by one of the notified
bodies specifically designated for that task; whereas the ma-
terials conforming to the European approvals shall be pre-
sumed to satisfy the essential requirements of this Directive;
(19) Whereas, in view of the nature of the hazards involved
in the use of pressure equipment it is necessary to establish
procedures for assessing compliance with the basic require-
ments of the Directives; whereas these procedures must be
devised in the light of the level of danger which is inherent in
the pressure equipment; whereas, therefore, for each catego-
ry of pressure equipment there must be an adequate proce-
dure or a choice between different procedures of equivalent
stringency; whereas the procedures adopted are as required
by Council Decision 93/465/EEC of 22 July 1993 concerning
the modules for the various phases of the conformity assess-
ment procedures and the rules for the affixing and use of the
CE conformity marking, which are intended to be used in the
technical harmonization Directives 8); whereas the details
added to these procedures are justified by the nature of the
verification required for pressure equipment;
7)
OJ No L 109, 26. 4. 1983, p. 8. Directive at last amended by the 1994
Act of Accession.
8)
OJ No L 220, 30. 8. 1993, p. 23.

(20) Whereas Member States should be in a position to
authorize user inspectorates to carry out certain tasks for
conformity assessment in the framework of this Directive;
whereas for that purpose this Directive sets out criteria for
the authorization of user inspectorates by Member States;
(21) Whereas, under the conditions laid down by this Di-
rective, certain procedures for conformity assessment may
require each item to be inspected and tested by a notified
body or a user inspectorate as part of the final assessment
of the pressure equipment; whereas in other cases provision
should be made to ensure that the final assessment may be
monitored by a notified body by means of unexpected visits;
(22) Whereas pressure equipment will, as a general rule,
bear the CE marking affixed either by the manufacturer or by
his authorized representative established within the Com-
munity; whereas the CE marking means that the pressure
equipment complies with the provisions of this Directive and
those of other applicable Community directives on CE mark-
ing; whereas for pressure equipment defined in this Direc-
tive which presents only a minor pressure hazard and for
which certification procedures are therefore not justified, the
CE marking will not be affixed;
(23) Whereas it is appropriate that the Member States, as
provided for by Article 100a of the Treaty, may take provi-
sional measures to limit or prohibit the placing on the mar-
ket, putting into service and use of pressure equipment in
cases where it presents a particular risk to the safety of per-
sons and, where appropriate, domestic animals or property,
provided that the measures are subject to a Community con-
trol procedure;
(24) Whereas the addressees of any decision taken under
this Directive must be aware of the reasons behind that de-
cision and the means of appeal open to them;
(25) Whereas it is necessary to lay down a transitional ar-
rangement enabling pressure equipment manufactured in
compliance with the national regulations in force on the date
of entry into force of this Directive to be marketed and put
into service;
(26) Whereas the requirements laid down in the Annexes
should be made as clear as possible so as to allow all users,
including small and medium-sized enterprises (SMEs), to
comply with them easily;
(27) Whereas an agreement on a modus vivendi between
the European Parliament, the Council and the Commission
concerning the implementing measures for acts adopted in
accordance with the procedure laid down in Article 189b of
the Treaty was reached on 20 December 1994 9),
HAVE ADOPTED THIS DIRECTIVE:
Article 1
Scope and definitions
(1) This Directive applies to the design, manufacture and
conformity assessment of pressure equipment and assem-
blies with a maximum allowable pressure PS greater than
0,5 bar.
(2) For the purposes of this Directive:
2.1 “Pressure equipment” means vessels, piping,
safety accessories and pressure accessories.
Where applicable, pressure equipment includes
elements attached to pressurized parts, such as
flanges, nozzles, couplings, supports, lifting lugs,
etc.
9)
OJ No C 102, 4. 4. 1996, p. 1.
PED, 02.1998 edition Page 3
2.1.1 “Vessel” means a housing designed and built to
contain fluids under pressure including its direct at-
tachments up to the coupling point connecting it to
other equipment. A vessel may be composed of
more than one chamber.
2.1.2 “Piping” means piping components intended for
the transport of fluids, when connected together
for integration into a pressure system. Piping in-
cludes in particular a pipe or system of pipes, tub-
ing, fittings, expansion joints, hoses, or other
pressure-bearing components as appropriate.
Heat exchangers consisting of pipes for the pur-
pose of cooling or heating air shall be considered
as piping.
2.1.3 “Safety accessories” means devices designed to
protect pressure equipment against the allowable
limits being exceeded. Such devices include:
– devices for direct pressure limitation, such as
safety valves, bursting disc safety devices,
buckling rods, controlled safety pressure relief
systems (CSPRS), and
– limiting devices, which either activate the
means for correction or provide for shutdown
or shutdown and lockout, such as pressure
switches or temperature switches or fluid level
switches and “safety related measurement
control and regulation (SRMCR)” devices.
2.1.4 “Pressure accessories” means devices with an op-
erational function and having pressure-bearing
housings.
2.1.5 “Assemblies” means several pieces of pressure
equipment assembled by a manufacturer to consti-
tute an integrated and functional whole.
2.2 “Pressure” means pressure relative to atmospheric
pressure, i.e. gauge pressure. As a consequence,
vacuum is designated by a negative value.
2.3 “Maximum allowable pressure PS” means the
maximum pressure for which the equipment is de-
signed, as specified by the manufacturer.
It is defined at a location specified by the manufac-
turer. This must be the location of connection of
protective and/or limiting devices or the top of
equipment or if not appropriate any point specified.
2.4 “Maximum/minimum allowable temperature TS”
means the maximum/minimum temperatures for
which the equipment is designed, as specified by
the manufacturer.
2.5 “Volume (V)” means the internal volume of a
chamber, including the volume of nozzles to the
first connection or weld and excluding the volume
of permanent internal parts.
2.6 “Nominal size (DN)” means a numerical designa-
tion of size which is common to all components in
a piping system other than components indicated
by outside diameters or by thread size. It is a con-
venient round number for reference purposes and
is only loosely related to manufacturing dimen-
sions. The nominal size is designated by DN fol-
lowed by a number.
2.7 “Fluids” means gases, liquids and vapours in pure
phase as well as mixtures thereof. A fluid may con-
tain a suspension of solids.
2.8 “Permanent joints” means joints which cannot be
disconnected except by destructive methods.
2.9 “European approval for materials” means a technical
document defining the characteristics of materials
Page 4 PED, 02.1998 edition
intended for repeated use in the manufacture of
pressure equipment which are not covered by any
harmonized standard.
(3) The following are excluded from the scope of this
Directive:
3.1 pipelines comprising piping or a system of piping
designed for the conveyance of any fluid or sub-
stance to or from an installation (onshore or off-
shore) starting from and including the last isolation
device located within the confines of the installa-
tion, including all the annexed equipment designed
specifically for pipelines. This exclusion does not
apply to standard pressure equipment such as
may be found in pressure reduction stations or
compression stations;
3.2 networks for the supply, distribution and discharge
of water and associated equipment and headraces
such as penstocks, pressure tunnels, pressure
shafts for hydroelectric installations and their relat-
ed specific accessories;
3.3 equipment covered by Directive 87/404/EEC on
simple pressure vessels;
3.4 equipment covered by Council Directive 75/324/
EEC of 20 May 1975 on the approximation of the
laws of the Member States relating to aerosol
dispensers10);
3.5 equipment intended for the functioning of vehicles
defined by the following Directives and their An-
nexes:
– Council Directive 70/156/EEC of 6 February
1970 on the approximation of the laws of the
Member States relating to the type-approval of
motor vehicles and their trailers11),
– Council Directive 74/150/EEC of 4 March 1974
on the approximation of the laws of the Mem-
ber States relating to the type-approval of
wheeled agricultural or forestry tractors12),
– Council Directive 92/61/EEC of 30 June 1992
relating to the type-approval of two or three-
wheel motor vehicles13);
3.6 equipment classified as no higher than category I
under Article 9 of this Directive and covered by one
of the following Directives:
– Council Directive 89/392/EEC of 14 June 1989
on the approximation of the laws of the Mem-
ber States relating to machinery14),
– European Parliament and Council Directive 95/
16/EC of 29 June 1995 on the approximation of
the laws of the Member States relating to
lifts15),
– Council Directive 73/23/EEC of 19 February
1973 on the harmonization of the laws of the
Member States relating to electrical equipment
designed for use within certain voltage limits16),
10)
OJ No L 147, 9. 6. 1975, p. 40. Directive as last amended by Com-
mission Directive 94/1/EC (OJ No L 23, 28. 1. 1994, p. 28).
11)
OJ No L 42, 23. 2. 1970, p. 1. Directive as last amended by Commis-
sion Directive 95/54/EC (OJ No L 266, 8. 11. 1995, p. 1).
12)
OJ No L 84, 28. 3. 1974, p. 10. Directive as last amended by the 1994
Act of Accession.
13)
OJ No L 225, 10. 8. 1992, p. 72. Directive as last amended by the
1994 Act of Accession.
14)
OJ No L 183, 29. 6. 1989, p. 9. Directive as last amended by Directive
93/68/EEC (OJ No L 220, 30. 8. 1993, p. 1).
15)
OJ No L 213, 7. 9. 1995, p. 1.
16)
OJ No L 77, 26. 3. 1973, p. 29. Directive as last amended by Directive
93/68/EEC (OJ No L 220, 30. 8. 1993, p. 1).
– Council Directive 93/42/EEC of 14 June 1993
concerning medical devices17),
– Council Directive 90/396/EEC of 29 June 1990
on the approximation of the laws of the Mem-
ber States relating to appliances burning gase-
ous fuels18),
– Directive 94/9/EC of the European Parliament
and the Council of 23 March 1994 on the ap-
proximation of the laws of the Member States
concerning equipment and protective systems
intended for use in potentially explosive atmos-
pheres19);
3.7 equipment covered by Article 223 (1) (b) of the
Treaty;
3.8 items specifically designed for nuclear use, failure
of which may cause an emission of radioactivity;
3.9 well-control equipment used in the petroleum, gas
or geothermal exploration and extraction industry
and in underground storage which is intended to
contain and/or control well pressure. This compris-
es the wellhead (Christmas tree), the blow out pre-
venters (BOP), the piping manifolds and all their
equipment upstream;
3.10 equipment comprising casings or machinery
where the dimensioning, choice of material and
manufacturing rules are based primarily on re-
quirements for sufficient strength, rigidity and sta-
bility to meet the static and dynamic operational
effects or other operational characteristics and for
which pressure is not a significant design factor.
Such equipment may include:
– engines including turbines and internal com-
bustion engines,
– steam engines, gas/steam turbines, turbo-gen-
erators, compressors, pumps and actuating
devices;
3.11 blast furnaces including the furnace cooling system,
hot-blast recuperators, dust extractors and blast-
furnace exhaust-gas scrubbers and direct reducing
cupolas, including the furnace cooling, gas convert-
ers and pans for melting, re-melting, de-gassing
and casting of steel and non-ferrous metals;
3.12 enclosures for high-voltage electrical equipment
such as switchgear, control gear, transformers,
and rotating machines;
3.13 pressurized pipes for the containment of transmis-
sion systems, e.g. for electrical power and tele-
phone cables;
3.14 ships, rockets, aircraft and mobile off-shore units,
as well as equipment specifically intended for in-
stallation on board or the propulsion thereof;
3.15 pressure equipment consisting of a flexible casing,
e.g. tyres, air cushions, balls used for play, inflata-
ble craft, and other similar pressure equipment;
3.16 exhaust and inlet silencers;
3.17 bottles or cans for carbonated drinks for final con-
sumption;
3.18 vessels designed for the transport and distribu-
tion of drinks having a PS · V of not more than
500 bar · L and a maximum allowable pressure
not exceeding 7 bar;
17)
OJ No L 169, 12. 7. 1993, p. 1.
18)
OJ No L 196, 26. 7. 1990, p. 15. Directive as last amended by Direc-
tive 93/68/EEC (OJ No L 220, 30. 8. 1993, p. 1).
19)
OJ No L 100, 19. 4. 1994, p. 1.

3.19 equipment covered by the ADR 20), the RID 21), the
IMDG 22) and the ICAO Convention 23);
3.20 radiators and pipes in warm water heating sys-
tems;
3.21 vessels designed to contain liquids with a gas
pressure above the liquid of not more than 0,5 bar.
Article 2
Market surveillance
(1) Member States shall take all appropriate measures to
ensure that the pressure equipment and the assemblies re-
ferred to in Article 1 may be placed on the market and put
into serive only if, when properly installed and maintained
and used for their intended purpose, they do not endanger
the health and safety of persons and, where appropriate, do-
mestic animals or property.
(2) The provisions of this Directive shall not affect Member
States’ entitlement to lay down, with due regard to the pro-
visions of the Treaty, such requirements as they may deem
necessary to ensure that persons and, in particular, workers
are protected during use of the pressure equipment or as-
semblies in question provided that this does not mean mod-
ifications to such equipment or assemblies in a way not
specified in this Directive.
(3) At trade fairs, exhibitions, demonstrations, etc., Mem-
ber States shall not prevent the showing of pressure equip-
ment or assemblies as defined in Article 1 not in conformity
with the provisions of this Directive, provided that a visible
sign clearly indicates their non-conformity and their non-
availability for sale until brought into conformity by the manu-
facturer or by his authorized representative established within
the Community. During demonstrations, appropriate safety
measures shall be taken in accordance with any require-
ments laid down by the competent authority of the Member
State concerned in order to ensure the safety of persons.
Article 3
Technical requirements
(1) The pressure equipment referred to in 1.1, 1.2, 1.3 and
1.4 must satisfy the essential requirements set out in
Annex I:
1.1 Vessels, except those referred to in 1.2 for:
a) gases, liquefied gases, gases dissolved under
pressure, vapours and also those liquids
whose vapour pressure at the maximum allow-
able temperature is greater than 0,5 bar above
normal atmospheric pressure, (1013 mbar)
within the following limits:
– for fluids in Group 1 with a volume greater
than 1 L and a product of PS and V greater
than 25 bar · L, or with a pressure PS great-
er than 200 bar (Annex II, table 1),
– for fluids in Group 2, with a volume greater
than 1 L and a product of PS and V is great-
er than 50 bar · L, or with a pressure PS
greater than 1 000 bar, and all portable ex-
tinguishers and bottles for breathing appa-
ratus (Annex II, table 2);
b) liquids having a vapour pressure at the maxi-
mum allowable temperature of not more than
20)
ADR = European Agreement concerning the International Carriage
of Dangerous Goods by Road.
21)
RID = Regulations concerning the International Carriage of Danger-
ous Goods by Rail.
22)
IMDG = International Maritime Dangerous Goods Code.
23)
ICAO = International Civil Aviation Organization.
PED, 02.1998 edition Page 5
0,5 bar above normal atmospheric pressure
(1 013 mbar) within the following limits:
– for fluids in Group 1 with a volume greater
than 1 L and a product of PS and V greater
than 200 bar · L, or with a pressure PS
greater than 500 bar (Annex II, table 3);
– for fluids in Group 2 with a pressure PS
greater than 10 bar and a product of PS
and V greater than 10 000 bar · L, or with a
pressure PS greater than 1000 bar
(Annex II, table 4).
1.2 Fired or otherwise heated pressure equipment
with the risk of overheating intended for generation
of steam or super-heated water at temperatures
higher than 110 °C having a volume greater than
2 L, and all pressure cookers (Annex II, table 5).
1.3 Piping intended for:
a) gases, liquified gases, gases dissolved under
pressure, vapours and those liquids whose va-
pour pressure at the maximum allowable tem-
perature is greater than 0,5 bar above normal
atmospheric pressure (1013 mbar) within the
following limits:
– for fluids in Group 1 with a DN greater than
25 (Annex II, table 6);
– for fluids in Group 2 with a DN greater than
32 and a product of PS and DN greater
than 1000 bar (Annex II, table 7).
b) liquids having a vapour pressure at the maxi-
mum allowable temperature of not more than
0,5 bar above normal atmospheric pressure
(1013 mbar), within the following limits:
– for fluids in Group 1 with a DN greater than
25 and a product of PS and DN greater
than 2000 bar (Annex II, table 8);
– for fluids in Group 2 with a PS greater than
10 bar, a DN greater than 200 and a prod-
uct of PS and DN greater than 5000 bar
(Annex II, table 9).
1.4 Safety and pressure accessories intended for
equipment covered by 1.1, 1.2 and 1.3 including
where such equipment is incorporated into an as-
sembly.
(2) The assemblies defined in Article 1 Section 2.1.5,
which include at least one item of pressure equipment cov-
ered by Section 1 of this Article and which are listed in 2.1,
2.2 and 2.3 of this Article must satisfy the essential require-
ments set out in Annex I.
2.1 Assemblies intended for generating steam or super-
heated water at a temperature higher than 110 °C
comprising at least one item of fired or otherwise
heated pressure equipment presenting a risk of
overheating.
2.2 Assemblies other than those referred to in 2.1, if
the manufacturer intends them to be placed on the
market and put into service as assemblies.
2.3 By way of derogation from the introductory para-
graph to this Section, assemblies intended for gen-
erating warm water at temperatures not greater
than 110 °C which are manually fed with solid fuels
and have a PS · V greater than 50 bar · L must
comply with the essential requirements referred to
in 2.10, 2.11, 3.4, 5 (a) and 5 (d) of Annex I.
(3) Pressure equipment and/or assemblies below or equal
to the limits in Sections 1.1, 1.2 and 1.3 and Section 2 respec-
tively must be designed and manufactured in accordance with
the sound engineering practice of a Member State in order to
Page 6 PED, 02.1998 edition
ensure safe use. Pressure equipment and/or assemblies
must be accompanied by adequate instructions for use and
must bear markings to permit identification of the manufactur-
er or of his authorized representative established within the
Community. Such equipment and/or assemblies must not
bear the CE marking referred to in Article 15.
Article 4
Free movement
(1) 1.1 Member States shall not, on grounds of the haz-
ards due to pressure, prohibit, restrict or impede
the placing on the market or putting into service
under the conditions specified by the manufacturer
of pressure equipment or assemblies referred to in
Article 1 which comply with this Directive and bear
the CE marking indicating that they have under-
gone conformity assessment in accordance with
Article 10.
1.2 Member States shall not, on grounds of the haz-
ards due to pressure, prohibit, restrict or impede
the placing on the market or putting into service of
pressure equipment or assemblies which comply
with Article 3 (3).
(2) Member States may require, to the extent that it is
needed for safe and correct use of pressure equipment and
assemblies, the information referred to in Annex I Sections
3.3 and 3.4 to be provided in the official language(s) of the
Community which may be determined in accordance with
the Treaty by the Member State in which the equipment or
assembly reaches the final user.
Article 5
Presumption of conformity
(1) Member States shall regard pressure equipment and
assemblies bearing the CE marking provided for in Article 15
and the EC declaration of conformity provided for in Annex VII
as conforming to all the provisions of this Directive, including
the conformity assessment provided for in Article 10.
(2) Pressure equipment and assemblies which conform to
the national standards transposing the harmonized stand-
ards the reference numbers of which have been published
in the Official Journal of the European Communities shall be
presumed to conform to the essential requirements referred
to in Article 3. Member States shall publish the reference
numbers of the national standards referred to above.
(3) Member States shall ensure that appropriate meas-
ures are taken to enable both sides of industry to have an
input at national level in the process of preparing and moni-
toring the harmonized standards.
Article 6
Committee on technical standards and regulations
Where a Member State or the Commission considers that
the standards referred to in Article 5 (2) do not entirely meet
the essential requirements referred to in Article 3, the Mem-
ber State concerned or the Commission shall inform the
Standing Committee set up by Article 5 of Directive 83/189/
EEC giving the reasons therefor. The Committee shall issue
an opinion as a matter of urgency.
Taking into account the Committee’s opinion, the Commis-
sion shall notify the Member States as to whether or not
those standards should be withdrawn from the publications
referred to in Article 5 (2).
Article 7
Committee on Pressure Equipment
(1) The Commission may take any appropriate measure to
implement the following provisions:
Where a Member State considers that, for very serious safety
reasons,
– an item or family of pressure equipment referred to in
Article 3 (3) should be subject to the requirements of
Article 3 (1), or
– an assembly or family of assemblies referred to in
Article 3 (3) should be subject to the requirements of
Article 3 (2), or
– an item or family of pressure equipment should be clas-
sified, by way of derogation from the requirements of
Annex II, in another category,
it shall submit a duly substantiated request to the Commis-
sion and ask it to take the necessary measures. Those
measures shall be adopted in accordance with the proce-
dure laid down in paragraph 3.
(2) The Commission shall be assisted by a standing com-
mittee, hereinafter referred to as “the Committee”, com-
posed of representatives appointed by the Member States
and chaired by a representative of the Commission.
The Committee shall draw up its rules of procedure.
(3) The representative of the Commission shall submit to
the Committee a draft of the measures to be taken pursuant
to paragraph 1. The Committee shall deliver its opinion on
the draft, within a time limit which the chairman may lay
down according to the urgency of the matter, if necessary by
taking a vote.
The opinion shall be recorded in the minutes; in addition, each
Member State shall have the right to ask to have its position
recorded in the minutes.
The Commission shall take the outmost account of the opinion
delivered by the Committee. It shall inform the Committee of
the manner in which its opinion has been taken into account.
(4) The Committee may furthermore examine any other
matter relating to the implementation and practical applica-
tion of this Directive and raised by its chairman either on his
own initiative or at the request of a Member State.
Article 8
Safeguard clause
(1) Where a Member State ascertains that pressure equip-
ment or assemblies referred to in Article 1, bearing the CE
marking and used in accordance with their intended use are
liable to endanger the safety of persons and, where appropri-
ate, domestic animals or property, it shall take all appropriate
measures to withdraw such equipment or assemblies from
the market, prohibit the placing on the market, putting into
service or use thereof, or restrict free movement thereof.
The Member State shall immediately inform the Commis-
sion of any such measure, indicating the reasons for its de-
cision and, in particular, whether non-conformity is due to:
a) failure to satisfy the essential requirements referred to in
Article 3;
b) incorrect application of the standards referred to in
Article 5 (2);
c) shortcomings in the standards referred to in Article 5 (2);
d) shortcomings in the European approval of pressure
equipment materials as referred to in Article 11.
(2) The Commission shall enter into consultation with the
parties concerned without delay. Where the Commission
considers, after this consultation, that the measure is justi-
fied, it shall immediately so inform the Member State which
took the initiative and the other Member States.
Where the Commission considers, after this consultation,
that the measure is unjustified, it shall immediately so inform

the Member State which took the initiative and the manufac-
turer, or his authorized representative established within the
Community. Where the decision referred to in paragraph 1
is based on a shortcoming in the standards or in European
approvals for materials and where the Member State at the
origin of the decision maintains its position the Commission
shall immediately inform the Committee referred to in
Article 6 in order to initiate the procedure referred to in the
first paragraph of Article 6.
(3) Where pressure equipment or an assembly which does
not comply bears the CE marking, the competent Member
State shall take appropriate action against the person(s)
having affixed the CE marking and shall so inform the Com-
mission and the other Member States.
(4) The Commission shall ensure that the Member Sates
are kept informed of the progress and outcome of this pro-
cedure.
Article 9
Classification of pressure equipment
(1) Pressure equipment referred to in Article 3 (1) shall be
classified by category in accordance with Annex II, accord-
ing to ascending level of hazard.
For the purposes of such classification fluids shall be divided
into two groups in accordance with 2.1 and 2.2.
(2) 2.1 Group 1 comprises dangerous fluids. A dangerous
fluid is a substance or preparation covered by the
definitions in Article 2 (2) of Council Directive
67/548/EEC of 27 June 1967 on the approximation
of the laws, regulations and administrative provi-
sions relating to the classification, packaging and
labelling of dangerous substances24).
Group 1 comprises fluids defined as:
– explosive,
– extremely flammable,
– highly flammable,
– flammable (where the maximum allowable tem-
perature is above flashpoint),
– very toxic,
– toxic,
– oxidizing.
2.2 Group 2 comprises all other fluids not referred to in
2.1.
(3) Where a vessel is composed of a number of chambers,
it shall be classified in the highest category applicable to the
individual chambers. Where a chamber contains several
fluids, classification shall be on the basis of the fluid which
requires the highest category.
Article 10
Conformity assessment
(1) 1.1 Before placing pressure equipment on the market,
the manufacturer shall subject each item of equip-
ment to one of the conformity assessment proce-
dures described in Annex III, according to the
conditions given in this Article.
1.2 The conformity assessment procedures to be ap-
plied to an item of pressure equipment with a view
to affixing the CE marking shall be determined by
the category, as defined in Article 9, in which the
equipment is classified.
1.3 The conformity assessment procedures to be ap-
plied for the various categories are as follows:
– category I
Module A;
24)
OJ No 196, 16. 8. 1967, p. 1. Directive as last amended by Commis-
sion Directive 94/69/EC (OJ No L 381, 31. 12. 1994, p. 1).
PED, 02.1998 edition Page 7
– category II
Module A1
Module D1
Module E1;
– category III
Module B1 + D
Module B1 + F
Module B + E
Module B + C1
Module H;
– category IV
Module B + D
Module B + F
Module G
Module H1.
1.4 Pressure equipment shall be subjected to one of
the conformity assessment procedures which may
be chosen by the manufacturer among those laid
down for the category in which it is classified. The
manufacturer may also choose to apply one of the
procedures which apply to a higher category, if
available.
1.5 In the framework of quality assurance procedures
for equipment in categories III and IV referred to in
Article 3, Section 1.1 (a), Section 1.1 (b) first indent
and Section 1.2, the notified body shall, when per-
forming unexpected visits, take a sample of equip-
ment from the manufacturing or storage premises
in order to perform, or have performed, the final as-
sessment as referred to in Annex I, Section 3.2.2.
To this end, the manufacturer shall inform the no-
tified body of the intended schedule of production.
The notified body shall carry out at least two visits
during the first year of manufacturing. The fre-
quency of subsequent visits shall be determined
by the notified body on the basis of the criteria set
out in Section 4.4 of the relevant modules.
1.6 In the case of one-off production of vessels and
equipment in category III referred to in Article 3,
Section 1.2 under the module H procedure, the no-
tified body shall perform or have performed the fi-
nal assessment, as referred to in Annex I, Section
3.2.2, for each unit. To this end, the manufacturer
shall communicate the intended schedule of pro-
duction to the notified body.
(2) Assemblies referred to in Article 3 (2) shall be subjected
to a global conformity assessment procedure comprising:
a) assessment of each item of pressure equipment making
up the assembly and referred to in Article 3 (1) which has
not been previously subjected to a conformity as-
sessment procedure and to a separate CE marking; the
assessment procedure shall be determined by the cate-
gory of each item of equipment;
b) the assessment of the integration of the various com-
ponents of the assembly as referred to in Sections 2.3,
2.8 and 2.9 of Annex I which shall be determined by the
highest category applicable to the equipment concerned
other than that applicable to any safety accessories;
c) the assessment of the protection of an assembly against
exceeding the permissible operating limits as referred to
in Sections 2.10 and 3.2.3 of Annex I shall be conducted
in the light of the highest category applicable to the items
of equipment to be protected.
(3) By way of derogation from paragraphs 1 and 2, the
competent authorities may, where justified, allow the placing
on the market and putting into service in the territory of the
Member State concerned of individual pressure equipment
Page 8 PED, 02.1998 edition
items and assemblies referred to in Article 1 (2), in respect
of which the procedures referred to in paragraphs 1 and 2 of
this Article have not been applied and the use of which is in
the interests of experimentation.
(4) Records and correspondence relating to conformity as-
sessment shall be drawn up in the official language(s) of the
Community which may be determined in accordance with
the Treaty by the Member State where the body responsible
for carrying out these procedures is established, or in a lan-
guage accepted by that body.
Article 11
uropean approval for materials
(1) European approval for materials, as defined in
Article 1, Section 2.9, shall be issued at the request of one
or more manufacturers of materials or equipment, by one of
the notified bodies referred to in Article 12 specifically des-
ignated for that task. The notified body shall determine and
perform, or arrange for the performance of, the appropriate
inspections and tests to certify the conformity of the types of
material with the corresponding requirements of this Direc-
tive; in the case of materials recognized as being safe to use
before 29 November 1999, the notified body shall take ac-
count of the existing data when certifying such conformity.
(2) Before issuing European approval for materials, the
notified body shall inform the Member States and the Com-
mission by sending them the appropriate information. Within
three months, a Member State or the Commission may refer
the matter to the Standing Committee set up by Article 5 of
Directive 83/189/EEC, giving its reasons. In that case, the
Committee shall issue an opinion as a matter of urgency.
The notified body shall issue the European approval for ma-
terials taking into account, where appropriate, the opinion of
the Committee and the comments submitted.
(3) A copy of the European approval for pressure equipment
materials shall be sent to the Member States, the notified
bodies and the Commission. The Commission shall publish
and keep up to date a list of European approvals for materials
in the Official Journal of the European Communities.
(4) The materials used for the manufacture of pressure
equipment conforming with European approvals for materi-
als, the references of which have been published in the Of-
ficial Journal of the European Communities, shall be
presumed to conform to the applicable essential require-
ments of Annex I.
(5) The notified body which issued the European approval
for pressure equipment materials shall withdraw that approval
if it finds that it should not have been issued or if the type of
materials is covered by a harmonized standard. It shall imme-
diately inform the other Member States, the notified bodies
and the Commission of any withdrawal of an approval.
Article 12
Notified bodies
(1) Member States shall notify the Commission and the
other Member States of the bodies which they have appoint-
ed to carry out the procedures referred to in Article 10 and
Article 11, together with the specific tasks which those bod-
ies have been appointed to carry out and the identification
numbers assigned to them beforehand by the Commission.
The Commission shall publish in the Official Journal of the
European Communities a list of the notified bodies, with
their identification numbers and the tasks for which they
have been notified. The Commission shall ensure that this
list is kept up to date.
(2) Member States shall apply the criteria set out in
Annex IV for the designation of bodies. Bodies meeting the
criteria laid down in the relevant harmonized standards shall
be presumed to fulfil the corresponding criteria in Annex IV.
(3) A Member State which has notified a body must with-
draw such notification if it finds that the body no longer
meets the criteria referred to in paragraph 2.
It shall forthwith inform the other Member States and the
Commission of any such withdrawal of a notification.
Article 13
Recognized third-party organizations
(1) Member States shall notify the Commission and the
other Member States of the third-party organizations which
they have recognized for the purposes of the tasks referred
to in Annex I, Sections 3.2.2 and 3.1.3.
The Commission shall publish in the Official Journal of the
European Communities a list of the recognized organiza-
tions with the tasks for which they have been recognized.
The Commission shall ensure that this list is kept up to date.
(2) Member States shall apply the criteria set out in
Annex IV for the recognition of organizations. Organizations
meeting the criteria laid down in the relevant harmonized
standards shall be presumed to fulfil the corresponding cri-
teria in Annex IV.
(3) A Member State which has recognized an organization
must withdraw such recognition if it finds that the organiza-
tion no longer meets the criteria referred to in paragraph 2.
It shall forthwith inform the other Member States and the
Commission of any such withdrawal of a recognition.
Article 14
User inspectorates
(1) By way of derogation from the provisions relating to the
tasks carried out by the notified bodies, Member States may
authorize in their territory the placing on the market, and the
putting into service by users, of pressure equipment or as-
semblies referred to in Article 1 of which conformity with the
essential requirements has been assessed by a user in-
spectorate designated in accordance with the criteria re-
ferred to in paragraph 8.
(2) When a Member State has designated a user inspec-
torate in accordance with the criteria set out in this Article, it
may not, on grounds of the hazards due to pressure, prohib-
it, restrict or impede the placing on the market or putting into
service under the conditions provided for in this Article of
pressure equipment or assemblies the conformity of which
has been assessed by a user inspectorate designated by
another Member State in accordance with the criteria set out
in this Article.
(3) Pressure equipment and assemblies the conformity of
which has been assessed by a user inspectorate shall not
bear the CE marking.
(4) The pressure equipment and assemblies referred to
may be used only in establishments operated by the group
of which the inspectorate is part. The group shall apply a
common safety policy as regards the technical specifica-
tions for the design, manufacture, inspection, maintenance
and use of pressure equipment and assemblies.
(5) The user inspectorates shall act exclusively for the
group of which they are part.
(6) The conformity assessment procedures applicable by
user inspectorates shall be modules A1, C1, F and G, as de-
scribed in Annex III.
(7) Member States shall inform the other Member States
and the Commission which user inspectorates they have au-
thorized, the tasks for which they have been designated
and, for each inspectorate, a list of the establishments sat-
isfying the provisions of paragraph 4.

(8) In designating the user inspectorates, the Member
States shall apply the criteria listed in Annex V and ensure
that the group of which the inspectorate is part applies the
criteria referred to in the second sentence of paragraph 4.
(9) A Member State that has authorized a user inspector-
ate shall withdraw that authorization if it finds that the user
inspectorate no longer meets the criteria referred to in para-
graph 8. It shall inform the other Member States and the
Commission thereof.
(10) The effects of this Article shall be monitored by the
Commission and evaluated three years after the date speci-
fied in Article 20 (3). To this end, Member States shall forward
to the Commission any useful information on the implementa-
tion of this Article. If necessary the evaluation shall be accom-
panied by a proposal for amendment of the Directive.
Article 15
CE marking
(1) The CE marking consists of the initials “CE” in accord-
ance with the model in Annex VI.
The CE marking shall be accompanied by the identification
number, as referred to in Article 12 (1), of the notified body
involved at the production control phase.
(2) The CE marking shall be affixed in a visible, easily leg-
ible and indelible fashion to each
– item of pressure equipment referred to in Article 3 (1), or
assembly referred to in Article 3 (2)
– which is complete or is in a state permitting final as-
sessment as described in Section 3.2 of Annex I.
(3) It is not necessary for the CE marking to be affixed to
each individual item of pressure equipment making up an as-
sembly as referred to in Article 3 (2). Individual items of pres-
sure equipment already bearing the CE marking when
incorporated into the assembly shall continue to bear that
marking.
(4) Where the pressure equipment or assembly is subject to
other Directives covering other aspects which provide for the
affixing of the CE marking, the latter shall indicate that the
pressure equipment or assembly in question is also pre-
sumed to conform to the provisions of those other Directives.
However, should one or more of those Directives allow the
manufacturer, during a transitional period, to choose which
arrangements to apply, the CE marking shall indicate con-
formity only with the Directives applied by the manufacturer.
In this case, the particulars of the said Directives, as pub-
lished in the Official Journal of the European Communities,
must be given in the documents, notices or instructions re-
quired by the Directives and accompanying the pressure
equipment or assembly.
(5) The affixing of markings on pressure equipment or as-
semblies which are likely to mislead third parties as to the
meaning or form of the CE marking shall be prohibited. Any
other marking may be affixed to pressure equipment or as-
semblies provided that the visibility and legibility of the CE
marking is not thereby reduced.
Article 16
Unduly affixed CE marking
Without prejudice to Article 8:
a) where a Member State establishes that the CE marking
PED, 02.1998 edition Page 9
has been affixed unduly, the manufacturer, or his autho-
rized representative established within the Community,
shall be obliged to make the product conform as regards
the provisions concerning the CE marking and to end the
infringement under the conditions imposed by the Mem-
ber State;
b) should non-conformity persist, the Member State must
take all appropriate measures to restrict or prohibit the
placing on the market of the product in question or to en-
sure that it is withdrawn from the market in accordance
with the procedures laid down in Article 8.
Article 17
Member States shall take appropriate measures in order to
encourage the authorities responsible for implementing this
Directive to cooperate with each other and provide each oth-
er and the Commission with information in order to assist the
functioning of this Directive.
Article 18
Decisions entailing refusal or restriction
Any decision taken pursuant to this Directive which restricts
the placing on the market and the putting into service or re-
quires the withdrawal from the market of pressure equip-
ment or assemblies shall state the exact grounds on which
it is based. Such decision shall be notified forthwith to the
party concerned, who shall at the same time be informed of
the legal remedies available to him under the laws in force
in the Member State concerned and of the time limits to
which such remedies are subject.
Article 19
Repeal
Article 22 of Directive 76/767/EEC shall cease to apply as
from 29 November 1999 in respect of pressure equipment
and assemblies covered by this Directive.
Article 20
Transposition and transitional provisions
(1) Before 29 May 1999 Member States shall adopt and
publish the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
inform the Commission thereof.
When Member States adopt the measures referred to in the
first subparagraph, they shall contain a reference to this Di-
rective or shall be accompanied by such reference on the
occasion of their official publication. The methods of making
such reference shall be laid down by Member States.
Member States shall apply such provisions as from 29 No-
vember 1999.
(2) Member States shall communicate to the Commission
the texts of the provisions of national law which they adopt
in the field governed by this Directive.
(3) Member States must permit the placing on the market
of pressure equipment and assemblies which comply with
the regulations in force in their territory at the date of appli-
cation of this Directive until 29 May 2002, and permit such
equipment and assemblies to be put into service beyond
that date.
Article 21
Addressees of the Directive
This Directive is addressed to the Member States.
Page 10 PED, 02.1998 edition
Annex I
ESSENTIAL SAFETY REQUIREMENTS
PRELIMINARY OBSERVATIONS
1. The obligations arising from the essential require-
ments listed in this Annex for pressure equipment
also apply to assemblies where the corresponding
hazard exists.
2. The essential requirements laid down in the Direc-
tive are compulsory. The obligations laid down in
these essential requirements apply only if the corre-
sponding hazard exists for the pressure equipment
in question when it is used under conditions which
are reasonably foreseeable by the manufacturer.
3. The manufacturer is under an obligation to analyse
the hazards in order to identify those which apply
to his equipment on account of pressure; he must
then design and construct it taking account of his
analysis.
4. The essential requirements are to be interpreted
and applied in such a way as to take account of the
state of the art and current practice at the time of
design and manufacture as well as of technical
and economic considerations which are consistent
with a high degree of health and safety protection.
1. GENERAL
1.1. Pressure equipment must be designed, manufac-
tured and checked, and if applicable equipped and
installed, in such a way as to ensure its safety when
put into service in accordance with the manufac-
turer’s instructions, or in reasonably foreseeable
conditions.
1.2. In choosing the most appropriate solutions, the
manufacturer must apply the principles set out be-
low in the following order:
– eliminate or reduce hazards as far as is rea-
sonably practicable,
– apply appropriate protection measures against
hazards which cannnot be eliminated,
– where appropriate, inform users of residual
hazards and indicate whether it is necessary to
take appropriate special measures to reduce
the risks at the time of installation and/or use.
1.3. Where the potential for misuse is known or can be
clearly foreseen, the pressure equipment must be
designed to prevent danger from such misuse or,
if that is not possible, adequate warning given that
the pressure equipment must not be used in that
way.
2. DESIGN
2.1. General
The pressure equipment must be properly de-
signed taking all relevant factors into account in or-
der to ensure that the equipment will be safe
throughout its intended life.
The design must incorporate appropriate safety
coefficients using comprehensive methods which
are known to incorporate adequate safety margins
against all relevant failure modes in a consistent
manner.
2.2. Design for adequate strength
2.2.1. The pressure equipment must be designed for
loadings appropriate to its intended use and other
reasonably foreseeable operating conditions. In
particular, the following factors must be taken into
account:
– internal/external pressure,
– ambient and operational temperatures,
– static pressure and mass of contents in operat-
ing and test conditions,
– traffic, wind, earthquake loading,
– reaction forces and moments which result from
the supports, attachments, piping, etc.,
– corrosion and erosion, fatigue, etc.,
– decomposition of unstable fluids.
Various loadings which can occur at the same time
must be considered, taking into account the prob-
ability of their simultaneous occurence.
2.2.2. Design for adequate strength must be based on:
– as a general rule, a calculation method, as
described in 2.2.3, and supplemented if
necessary by an experimental design
method as described in 2.2.4, or
– an experimental design method without
calculation, as described in 2.2.4, when the
product of the maximum allowable pres-
sure PS and the volume V is less than
6000 bar · L or the product PS · DN less
than 3000 bar.
2.2.3. Calculation method
a) Pressure containment and other loading aspects
The allowable stresses for pressure equipment
must be limited having regard to reasonably
foreseeable failure modes under operating
conditions. To this end, safety factors must be
applied to eliminate fully any uncertainty aris-
ing out of manufacture, actual operational con-
ditions, stresses, calculation models and the
properties and behaviour of the material.
These calculation methods must provide suffi-
cient safety margins consistent, where applica-
ble, with the requirements of Section 7.
The requirements set out above may be met by
applying one of the following methods, as ap-
propriate, if necessary as a supplement to or in
combination with another method:
– design by formula,
– design by analysis,
– design by fracture mechanics;
b) Resistance
Appropriate design calculations must be used
to establish the resistance of the pressure
equipment concerned.
In particular:
– the calculation pressures must not be less
than the maximum allowable pressures and
take into account static head and dynamic
fluid pressures and the decomposition of un-
stable fluids. Where a vessel is separated
into individual pressure-containing cham-
bers, the partition wall must be designed on
the basis of the highest possible chamber

pressure relative to the lowest pressure pos-
sible in the adjoining chamber,
– the calculation temperatures must allow for
appropriate safety margins,
– the design must take appropriate account of
all possible combinations of temperature
and pressure which might arise under rea-
sonably foreseeable operating conditions for
the equipment,
– the maximum stresses and peak stress con-
centrations must be kept within safe limits,
– the calculation for pressure containment
must utilize the values appropriate to the
properties of the material, based on docu-
mented data, having regard to the provi-
sions set out in Section 4 together with
appropriate safety factors. Material charac-
teristics to be considered, where applicable,
include:
– yield strength, 0,2 % or 1,0 % proof
strength as appropriate at calculation
temperature,
– tensile strength,
– time-dependent strength, i.e. creep
strength,
– fatigue data,
– Young’s modulus (modulus of elasticity),
– appropriate amount of plastic strain,
– impact strength,
– fracture toughness,
– appropriate joint factors must be applied to
the material properties depending, for ex-
ample, on the type of non-destructive test-
ing, the materials joined and the operating
conditions envisaged,
– the design must take appropriate account
of all reasonably foreseeable degradation
mechanisms (e.g. corrosion, creep, fa-
tigue) commensurate with the intended use
of the equipment. Attention must be drawn,
in the instructions referred to in Section 3.4,
to particular features of the design which
are relevant to the life of the equipment, for
example:
– for creep: design hours of operation at
specified temperatures,
– for fatigue: design number of cycles at
specified stress levels,
– for corrosion: design corrosion allow-
ance;
c) Stability aspects
Where the calculated thickness does not allow for
adequate structural stability, the necessary meas-
ures must be taken to remedy the situation taking
into account the risks from transport and handling.
2.2.4. Experimental design method
The design of the equipment may be validated, in
all or in part, by an appropriate test programme
carried out on a sample representative of the
equipment or the category of equipment.
The test programme must be clearly defined prior
to testing and accepted by the notified body re-
sponsible for the design conformity assessment
module, where it exists.
This programme must define test conditions and cri-
teria for acceptance or refusal. The actual values of
the essential dimensions and characteristics of the
PED, 02.1998 edition Page 11
materials which constitute the equipment tested
shall be measured before the test.
Where appropriate, during tests, it must be possi-
ble to observe the critical zones of the pressure
equipment with adequate instrumentation capable
of registering strains and stresses with sufficient
precision.
The test programme must include:
a) A pressure strength test, the purpose of which
is to check that, at a pressure with a defined
safety margin in relation to the maximum allow-
able pressure, the equipment does not exhibit
significant leaks or deformation exceeding a
determined threshold.
The test pressure must be determined on the
basis of the differences between the values of
the geometrical and material characteristics
measures under test conditions and the values
used for design purposes; it must take into ac-
count the differences between the test and de-
sign temperatures;
b) where the risk of creep or fatigue exists, appro-
priate tests determined on the basis of the serv-
ice conditions laid down for the equipment, for
instance hold time at specified temperatures,
number of cycles at specified stress-levels, etc.;
c) where necessary, additional tests concerning
other factors referred to in 2.2.1 such as corro-
sion, external damage, etc.
2.3. Provisions to ensure safe handling and operation
The method of operation specified for pressure
equipment must be such as to preclude any rea-
sonably foreseeable risk in operation of the equip-
ment. Particular attention must be paid, where
appropriate, to:
– closures and openings,
– dangerous discharge of pressure relief blow-off,
– devices to prevent physical access whilst pres-
sure or a vacuum exists,
– surface temperature taking into consideration
the intended use,
– decomposition of unstable fluids.
In particular, pressure equipment fitted with an ac-
cess door must be equipped with an automatic or
manual device enabling the user easily to ascer-
tain that the opening will not present any hazard.
Furthermore, where the opening can be operated
quickly, the pressure equipment must be fitted with
a device to prevent it being opened whenever the
pressure or temperature of the fluid presents a
hazard.
2.4. Means of examination
a) Pressure equipment must be designed and
constructed so that all necessary examinations
to ensure safety can be carried out;
b) Means of determining the internal condition of
the equipment must be available, where it is
necessary to ensure the continued safety of
the equipment, such as access openings al-
lowing physical access to the inside of the
pressure equipment so that appropriate exam-
inations can be carried out safely and ergo-
nomically;
c) Other means of ensuring the safe condition of
the pressure equipment may be applied:
– where it is too small for physical internal ac-
cess, or
– where opening the pressure equipment
would adversely affect the inside, or
Page 12 PED, 02.1998 edition
– where the substance contained has been
shown not to be harmful to the material
from which the pressure equipment is
made and no other internal degradation
mechanisms are reasonably foreseeable.
2.5. Means of draining and venting
Adequate means must be provided for the draining
and venting of pressure equipment where neces-
sary:
– to avoid harmful effects such as water ham-
mer, vacuum collapse, corrosion and uncon-
trolled chemical reactions. All stages of
operation and testing, particularly pressure
testing, must be considered,
– to permit cleaning, inspection and mainte-
nance in a safe manner.
2.6. Corrosion or other chemical attack
Where necessary, adequate allowance or protec-
tion against corrosion or other chemical attack
must be provided, taking due account of the in-
tended and reasonably foreseeable use.
2.7. Wear
Where severe conditions of erosion or abrasion
may arise, adequate measures must be taken to:
– minimize that effect by appropriate design, e.g.
additional material thickness, or by the use of
liners or cladding materials,
– permit replacement of parts which are most af-
fected,
– draw attention, in the instructions referred to in
3.4, to measures necessary for continued safe
use.
2.8. Assemblies
Assemblies must be so designed that:
– the components to be assembled together are
suitable and reliable for their duty,
– all the components are properly integrated and
assembled in an appropriate manner.
2.9. Provisions for filling and discharge
Where appropriate, the pressure equipment must
be so designed and provided with accessories, or
provision made for their fitting, as to ensure safe
filling and discharge in particular with respect to
hazards such as:
a) on filling:
– overfilling or overpressurization having re-
gard in particular to the filling ratio and to
vapour pressure at the reference tempera-
ture,
– instability of the pressure equipment;
b) on discharge: the uncontrolled release of the
pressurized fluid;
c) on filling or discharge: unsafe connection and
disconnection.
2.10. Protection against exceeding the allowable limits
of pressure equipment
Where, under reasonably foreseeable conditions,
the allowable limits could be exceeded, the pres-
sure equipment must be fitted with, or provision
made for the fitting of, suitable protective devices,
unless the equipment is intended to be protected
by other protective devices within an assembly.
The suitable device or combination of such devic-
es must be determined on the basis of the particu-
lar characteristics of the equipment or assembly.
Suitable protective devices and combinations
thereof comprise:
a) safety accessories as defined in Article 1, Sec-
tion 2.1.3,
b) where appropriate, adequate monitoring devic-
es such as indicators and/or alarms which en-
able adequate action to be taken either
automatically or manually to keep the pressure
equipment within the allowable limits.
2.11. Safety accessories
2.11.1. Safety accessories must:
– be so designed and constructed as to be relia-
ble and suitable for their intended duty and
take into account the maintenance and testing
requirements of the devices, where applicable,
– be independent of other functions, unless their
safety function cannot be affected by such oth-
er functions,
– comply with appropriate design principles in or-
der to obstain suitable and reliable protection.
These principles include, in particular, fail-safe
modes, redundancy, diversity and self-diagno-
sis.
2.11.2. Pressure limiting devices
These devices must be so designed that the pres-
sure will not permanently exceed the maximum al-
lowable pressure PS; however a short duration
pressure surge in keeping with the specifications
laid down in 7.3 is allowable, where appropriate.
2.11.3. Temperature monitoring devices
These devices must have an adequate response
time on safety grounds, consistent with the meas-
urement function.
2.12. External fire
Where necessary, pressure equipment must be so
designed and, where appropriate, fitted with suita-
ble accesssories, or provision made for their fitting,
to meet damage-limitation requirements in the
event of external fire, having particular regard to its
intended use.
3. MANUFACTURING
3.1. Manufacturing procedures
The manufacturer must ensure the competent ex-
ecution of the provisions set out at the design
stage by applying the appropriate techniques and
relevant procedures, especially with a view to the
aspects set out below.
3.1.1. Preparation of the component parts
Preparation of the component parts (e.g. forming
and chamfering) must not give rise to defects or
cracks or changes in the mechanical characteris-
tics likely to be detrimental to the safety of the
pressure equipment.
3.1.2. Permanent joining
Permanent joints and adjacent zones must be free
of any surface or internal defects detrimental to the
safety of the equipment.
The properties of permanent joints must meet the
minimum properties specified for the materials to
be joined unless other relevant property values are
specifically taken into account in the design calcu-
lations.

For pressure equipment, permanent joining of
components which contribute to the pressure re-
sistance of equipment and components which are
directly attached to them must be carried out by
suitably qualified personnel according to suitable
operating procedures.
For pressure equipment in categories II, III and IV,
operating procedures and personnel must be ap-
proved by a competent third party which, at the
manufacturer’s discretion, may be:
– a notified body,
– a third-party organization recognized by a
Member State as provided for in Article 13.
To carry out these approvals the third party must
perform examinations and tests as set out in the
appropriate harmonized standards or equivalent ex-
aminations and tests or must have them performed.
3.1.3. Non-destructive tests
For pressure equipment, non-destructive tests of
permanent joints must be carried out by suitable
qualified personnel. For pressure equipment in
categories III and IV, the personnel must be ap-
proved by a third-party organization recognized by
a Member State pursuant to Article 13.
3.1.4. Heat treatment
Where there is a risk that the manufacturing proc-
ess will change the material properties to an extent
which would impair the safety of the pressure
equipment, suitable heat treatment must be ap-
plied at the appropriate stage of manufacture.
3.1.5. Traceability
Suitable procedures must be established and
maintained for identifying the material making up
the components of the equipment which contribute
to pressure resistance by suitable means from re-
ceipt, through production, up to the final test of the
manufactured pressure equipment.
3.2. Final assessment
Pressure equipment must be subjected to final as-
sessment as described below.
3.2.1. Final inspection
Pressure equipment must undergo a final inspec-
tion to assess visually and by examination of the
accompanying documents compliance with the re-
quirements of the Directive. Test carried out during
manufacture may be taken into account. As far as is
necessary on safety grounds, the final inspection
must be carried out internally and externally on eve-
ry part of the equipment, where appropriate in the
course of manufacture (e.g. where examination dur-
ing the final inspection is no longer possible).
3.2.2. Proof test
Final assessment of pressure equipment must in-
clude a test for the pressure containment aspect,
which will normally take the form of a hydrostatic
pressure test at a pressure at least equal, where
appropriate, to the value laid down in 7.4.
For category I series-produced pressure equipment,
this test may be performed on a statistical basis.
Where the hydrostatic pressure test is harmful or
impractical, other tests of a recognized value may
be carried out. For tests other than the hydrostatic
pressure test, additional measures, such as non-
destructive tests or other methods of equivalent
validity, must be applied before those tests are
carried out.
PED, 02.1998 edition Page 13
3.2.3. Inspection of safety devices
For assemblies, the final assessment must also in-
clude a check of the safety devices intended to
check full compliance with the requirements re-
ferred to in 2.10.
3.3. Marking and labelling
In addition to the CE marking referred to in Article
15, the following information must be provided:
a) for all pressure equipment:
– the name and address or other means of
identification of the manufacturer and, where
appropriate, of his authorized representative
established within the Community,
– the year of manufacture,
– identification of the pressure equipment ac-
cording to its nature, such as type, series or
batch identification and serial number,
– essential maximum/minimum allowable lim-
its;
b) depending on the type of pressure equipment,
further information necessary for safe installa-
tion, operation or use and, where applicable,
maintenance and periodic inspection such as:
– the volume V of the pressure equipment in
L,
– the nominal size for piping DN,
– the test pressure PT applied in bar and date,
– safety device set pressure in bar,
– output of the pressure equipment in kW,
– supply voltage in V (volts),
– intended use,
– filling ratio kg/L,
– maximum filling mass in kg,
– tare mass in kg,
– the product group;
c) where necessary, warnings fixed to the pres-
sure equipment drawing attention to misuse
which experience has shown might occur.
The CE marking and the required information
must be given on the pressure equipment or on
a dataplate firmly attached to it, with the follow-
ing exceptions:
– where applicable, appropriate documenta-
tion may be used to avoid repetitive marking
of individual parts such as piping compo-
nents, intended for the same assembly. This
applies to CE marking and other marking
and labelling referred to in this Annex;
– where the pressure equipment is too small,
e.g. accessories, the information referred
to in (b) may be given on a label attached to
that pressure equipment;
– labelling or other adequate means may be
used for the mass to be filled and the warn-
ings referred to in (c), provided it remains
legible for the appropriate period of time.
3.4. Operating instructions
a) When pressure equipment is placed on the
market, it must be accompanied, as far as rel-
evant, with instructions for the user, containing
all the necessary safety information relating to:
– mounting including assembling of different
pieces of pressure equipment,
– putting into service,
– use,
– maintenance including checks by the user;
Page 14 PED, 02.1998 edition
b) Instructions must cover information affixed to
the pressure equipment in accordance with
3.3, with the exception of serial identification,
and must be accompanied, where appropriate,
by the technical documents, drawings and dia-
grams necessary for a full understanding of
these instructions;
c) If appropriate, these instructions must also re-
fer to hazards arising from misuse in accord-
ance with 1.3 and particular features of the
design in accordance with 2.2.3.
4. MATERIALS
Materials used for the manufacture of pressure
equipment must be suitable for such application
during the scheduled lifetime unless replacement
is foreseen.
Welding consumables and other joining materials
need fulfil only the relevant requirements of 4.1, 4.2
(a) and the first paragraph of 4.3, in an appropriate
way, both individually and in a joined structure.
4.1. Materials for pressurized parts must:
a) have appropriate properties for all operating
conditions which are reasonably foreseeable
and for all test conditions, and in particular they
should be sufficiently ductile and tough. Where
appropriate, the characteristics of the materials
must comply with the requirements of 7.5.
Moreover, due care should be exercised in par-
ticular in selecting materials in order to prevent
brittle-type fracture where necessary; where
for specific reasons brittle material has to be
used appropriate measures must be taken;
b) be sufficiently chemically resistant to the fluid
contained in the pressure equipment; the
chemical and physical properties necessary for
operational safety must not be significantly af-
fected within the scheduled lifetime of the
equipment;
c) not be significantly affected by ageing;
d) be suitable for the intended processing proce-
dures;
e) be selected in order to avoid significant unde-
sirable effects when the various materials are
put together.
4.2. a) The pressure equipment manufacturer must de-
fine in an appropriate manner the values neces-
sary for the design calculations referred to in
2.2.3 and the essential characteristics of the
materials and their treatment referred to in 4.1;
b) the manufacturer must provide in his technical
documentation elements relating to compli-
ance with the materials specifications of the Di-
rective in one of the following forms:
– by using materials which comply with har-
monized standards,
– by using materials covered by a European
approval of pressure equipment materials
in accordance with Article 11,
– by a particular material appraisal;
c) for pressure equipment in categories III and IV,
particular appraisal as referred to in the third in-
dent of (b) must be performed by the notified
body in charge of conformity assessment pro-
cedures for the pressure equipment.
4.3. The equipment manufacturer must take appropri-
ate measures to ensure that the material used con-
forms with the required specification. In particular,
documentation prepared by the material manufac-
turer affirming compliance with a specification
must be obtained for all materials.
For the main pressure-bearing parts of equipment
in categories II, III and IV, this must take the form
of a certificate of specific product control.
Where a material manufacturer has an appropriate
quality-assurance system, certified by a compe-
tent body established within the Community and
having undergone a specific assessment for mate-
rials, certificates issued by the manufacturer are
presumed to certify conformity with the relevant re-
quirements of this Section.
SPECIFIC PRESSURE EQUIPMENT REQUIREMENTS
In addition to the applicable requirements of Sections 1, 2, 3
and 4, the following requirements apply to the pressure
equipment covered by Sections 5 and 6.
5. FIRED OR OTHERWISE HEATED PRESSURE
EQUIPMENT WITH A RISK OF OVERHEATING
AS REFERRED TO IN ARTICLE 3 (1)
This pressure equipment includes:
– steam and hot-water generators as referred to
in Article 3, Section 1.2, such as fired steam
and hot-water boilers, superheaters and re-
heaters, waste-heat boilers, waste incineration
boilers, electrode or immersion-type electrical-
ly heated boilers, pressure cookers, together
with their accessories and where applicable
their systems for treatment of feedwater and
for fuel supply, and
– process-heating equipment for other than
steam and hot water generation falling under
Article 3, Section 1.1, such as heaters for
chemical and other similar processes and
pressurized food-processing equipment.
This pressure equipment must be calculated, de-
signed and constructed so as to avoid to minimize
risks of a significant loss of containment from over-
heating. In particular it must be ensured, where ap-
plicable, that:
a) appropriate means of protection are provided
to restrict operating parameters such as heat
input, heat take-off and, where applicable, fluid
level so as to avoid any risk of local and general
overheating,
b) sampling points are provided where required to
allow evaluation of the properties of the fluid so
as to avoid risks related to deposits and/or cor-
rosion,
c) adequate provisions are made to eliminate
risks of damage from deposits,
d) means of safe removal of residual heat after
shutdown are provided,
e) steps are taken to avoid a dangerous accumu-
lation of ignitable mixtures of combustible sub-
stances and air, or flame blowback.
6. PIPING AS REFERRED TO IN ARTICLE 3,
SECTION 1.3
Design and construction must ensure:
a) that the risk of overstressing from inadmissible
free movement or excessive forces being pro-
duced, e.g. on flanges, connections, bellows or
hoses, is adequately controlled by means such
as support, constraint, anchoring, alignment
and pre-tension;

b) that where there is a possibility of condensa-
tion occurring inside pipes for gaseous fluids,
means are provided for drainage and removal
of deposits from low areas to avoid damage
from water hammer or corrosion;
c) that due consideration is given to the potential
damage from turbulence and formation of vor-
tices; the relevant parts of 2.7 are applicable;
d) that due consideration is given to the risk of fa-
tigue due to vibrations in pipes;
e) that, where fluids of Group 1 are contained in
the piping, appropriate means are provided to
isolate “take-off” pipes the size of which repre-
sents a significant risk;
f) that the risk of inadvertent discharge is mini-
mized; the take-off points must be clearly
marked on the permanent side, indicating the
fluid contained;
g) that the position and route of underground pip-
ing is at least recorded in the technical docu-
mentation to facilitate safe maintenance,
inspection or repair.
7. SPECIFIC QUANTITATIVE REQUIREMENTS FOR
CERTAIN PRESSURE EQUIPMENT
The following provisions apply as a general rule.
However, where they are not applied, including in
cases where materials are not specifically referred
to and no harmonized standards are applied, the
manufacturer must demonstrate that appropriate
measures have been taken to achieve an equiva-
lent overall level of safety.
This Section is an integral part of Annex I. The pro-
visions laid down in this Section supplement the
essential requirements of Sections 1, 2, 3, 4, 5 and
6 for the pressure equipment to which they apply.
7.1. Allowable stresses
7.1.1. Symbols
Re/t, yield limit, indicates the value at the calcula-
tion temperature of:
– the upper flow limit for a material presenting
upper and lower flow limits,
– the 1,0 % proof strength of austenitic steel and
non-alloyed aluminium,
– the 0,2 % proof strength in other cases.
Rm/20 indicates the minimum value of the ultimate
strength 20°C.
Rm/t designates the ultimate strength at the calcu-
lation temperature.
7.1.2. The permissible general membrane stress for pre-
dominantly static loads and for temperatures out-
side the range in which creep is significant must
not exceed the smaller of the following values, ac-
cording to the material used:
– in the case of ferritic steel including normalized
(normalized rolled) steel and excluding fine-
grained steel and specially heat-treated steel,
2
/3 of Re/t and 5/12 of Rm/20;
PED, 02.1998 edition Page 15
– in the case of austenitic steel:
– if its elongation after rupture exceeds 30 %,
2
/3 of Re/t;
– or, alternatively, and if its elongation after
rupture exceeds 35 %, 5/6 of Re/t and 1/3 of
Rm,/t;
– in the case of non-alloy or low-alloy cast steel,
10
/19 of Re/t and 1/3 of Rm/20;
– in the case of aluminium, 2/3 of Re/t;
– in the case of aluminium alloys excluding pre-
cipitation hardening alloys, 2/3 of Re/t and 5/12 of
Rm/20.
7.2. Joint coefficients
For welded joints, the joint coefficient must not ex-
ceed the following values:
– for equipment subject to destructive and non-
destructive tests which confirm that the whole
series of joints show no significant defects: 1,
– for equipment subject to random non-destruc-
tive testing: 0,85,
– for equipment not subject to non-destructive
testing other than visual inspection: 0,7.
If necessary, the type of stress and the mechanical
and technological properties of the joint must also
be taken into account.
7.3. Pressure limiting devices, particularly for pressure
vessels
The momentary pressure surge referred to in
2.11.2 must be kept to 10 % of the maximum allow-
able pressure.
7.4. Hydrostatic test pressure
For pressure vessels, the hydrostatic test pressure
referred to in 3.2.2 must be no less than:
– that corresponding to the maximum loading to
which the pressure equipment may be subject
in service taking into account its maximum al-
lowable pressure and its maximum allowable
temperature, multiplied by the coefficient 1,25,
or
– the maximum allowable pressure multiplied by
the coefficient 1,43, whichever is the greater.
7.5. Material characteristics
Unless other values are required in accordance
with other criteria that must be taken into account,
a steel is considered as sufficiently ductile to satis-
fy 4.1 (a) if, in a tensile test carried out by a stand-
ard procedure, its elongation after rupture is no
less than 14 % and its bending rupture energy
measured on an ISO V test-piece is no less than
27 J, at a temperature not greater than 20°C but
not higher than the lowest scheduled operating
temperature.
Page 16 PED, 02.1998 edition

Annex II
Conformity assessment tables

1. The references in the tables to categories of mod-
ules are the following:
I = Module A
II = Modules A1, D1, E1
III = Modules B1 + D, B1 + F, B + E, B + C1, H
IV = Modules B + D, B + F, G, H1
2. The safety accessories defined in Article 1, Sec-
tion 2.1.3, and referred to in Article 3, Section 1.4,
are classified in category IV. However, by way of
exception, safety accessories manufactured for
specific equipment may be classified in the same
category as the equipment they protect.
3. The pressure accessories defined in Article 1,
Section 2.1.4, and referred to in Article 3, Section
1.4, are classified on the basis of:
– their maximum allowable pressure PS, and
– their volume V or their nominal size DN, as ap-
propriate, and
– the group of fluids for which they are intended,
and the appropriate table for vessels or piping is to
be used to determine the conformity assessment
category.
Where both the volume and the nominal size are
considered appropriate in the second indent, the
pressure accessory must be classified in the high-
est category.
4. The demarcation lines in the following conformity
assessment tables indicate the upper limit for each
category.

Table 1
Vessels referred to in Article 3, Section 1.1 a), first indent
Exceptionally, vessels intended to contain an unstable gas and falling within categories I or II
on the basis of table 1 must be classified in category III.
 PED, 02.1998 edition Page 17

Table 2
Vessels referred to in Article 3, Section 1.1 a), second indent
Exceptionally, portable extinguishers and bottles for breathing equipment must be classified at least in category III.

Table 3
Vessels referred to in Article 3, Section 1.1 b), first indent
Page 18 PED, 02.1998 edition

Table 4
Vessels referred to in Article 3, Section 1.1 b), second indent
Exceptionally, assemblies intended for generating warm water as referred to in Article 3, Sec-
tion 2.3, must be subject either to an EC design examination (Module B1) with respect to their
conformity with the essential requirements referred to in Annex I, Sections 2.10, 2.11, 3.4, 5 (a)
and 5 (d), or to full quality assurance (Module H).

Table 5
Pressure equipment referred to in Article 3, Section 1.2
Exceptionally, the design of pressure-cookers must be subject to a conformity
assessment procedure equivalent to at least one of the category III modules.
 PED, 02.1998 edition Page 19

Table 6
Piping referred to in Article 3, Section 1.3 a), first indent
Exceptionally, piping intended for unstable gases and falling within categories I or II
on the basis of Table 6 must be classified in category III.

Table 7
Piping referred to in Article 3, Section 1.3 a), second indent
Exceptionally, all piping containing fluids at a temperature greater than 350°C and
falling within category II on the basis of Table 7 must be classified in category III.
Page 20 PED, 02.1998 edition

Table 8
Piping referred to in Article 3, Section 1.3 b), first indent

Table 9
Piping referred to in Article 3, Section 1.3 b), second indent

Annex III
CONFORMITY ASSESSMENT PROCEDURES
The obligations arising from the provisions on pressure
equipment in this Annex also apply to assemblies.
Module A (internal production control)
1. This module describes the procedure whereby the
manufacturer or his authorized representative es-
tablished within the Community who carries out the
obligations laid down in Section 2 ensures and de-
clares that pressure equipment satisfies the re-
quirements of the Directive which apply to it. The
manufacturer, or his authorized representative es-
tablished within the Community, must affix the CE
marking to each item of pressure equipment and
draw up a written declaration of conformity.
2. The manufacturer must draw up the technical docu-
mentation described in Section 3 and either the
manufacturer or his authorized representative es-
tablished within the Community must keep it at the
disposal of the relevant national authorities for in-
spection purposes for a period of ten years after the
last of the pressure equipment has been manufac-
tured.
Where neither the manufacturer nor his authorized
representative is established within the Community,
the obligation to keep the technical documentation
available is the responsibility of the person who
places the pressure equipment on the Community
market.
3. The technical documentation must enable an as-
sessment to be made of the conformity of the pres-
sure equipment with the requirements of the
Directive which apply to it. It must, as far as is rele-
vant for such assessment, cover the design, manu-
facture and operation of the pressure equipment
and contain:
– a general description of the pressure equip-
ment,
– conceptual design and manufacturing draw-
ings and diagrams of components, sub-assem-
blies, circuits, etc.,
– descriptions and explanations necessary for an
understanding of the said drawings and dia-
grams and the operation of the pressure equip-
ment,
– a list of the standards referred to in Article 5,
applied in full or in part, and a description of the
solutions adopted to meet the essential re-
quirements of the Directive where the stand-
ards referred to in Article 5 have not been
applied,
– results of design calculations made, examina-
tions carried out, etc.,
– test reports.
4. The manufacturer, or his authorized representa-
tive established within the Community, must keep
a copy of the declaration of conformity with the
technical documentation.
5. The manufacturer must take all measures neces-
sary to ensure that the manfacturing process re-
quires the manufactured pressure equipment to
comply with the technical documentation referred
to in Section 2 and with the requirements of the Di-
rective which apply to it.
PED, 02.1998 edition Page 21
Module A1 (internal manufacturing checks with
monitoring of the final assessment)
In addition to the requirements of module A, the following
applies.
Final assessment must be performed by the manufacturer
and monitored by means of unexpected visits by a notified
body chosen by the manufacturer.
During such visits, the notified body must:
– establish that the manufacturer actually performs final
assessment in accordance with Section 3.2 of Annex I,
– take samples of pressure equipment at the manufactu-
ring or storage premises in order to conduct checks. The
notified body assesses the number of items of equip-
ment to sample and whether it is necessary to perform,
or have performed, all or part of the final assessment of
the pressure equipment samples.
Should one or more of the items of pressure equipment not
conform, the notified body must take appropriate measures.
On the responsibility of the notified body, the manufacturer
must affix the former’s identification number on each item of
pressure equipment.
Module B (EC type-examination)
1. This module describes the part of the procedure by
which a notified body ascertains and attests that a
representative example of the production in ques-
tion meets the provisions of the Directive which ap-
ply to it.
2. The application for EC type-examination must be
lodged by the manufacturer or by his authorized
representative established within the Community
with a single notified body of his choice.
The application must include:
– the name and address of the manufacturer
and, if the application is lodged by the author-
ized representative, his name and address as
well,
– a written declaration that the same application
has not been lodged with any other notified
body,
– the technical documentation described in Sec-
tion 3.
The applicant must place at the disposal of the no-
tified body a representative example of the produc-
tion envisaged, hereinafter called “type”. The
notified body may request further examples should
the test programme so require.
A type may cover several versions of pressure
equipment provided that the differences between
the versions do not affect the level of safety.
3. The technical documentation must enable an as-
sessment to be made of the conformity of the pres-
sure equipment with the requirements of the
Directive which apply to it. It must, as far as is rel-
evant for such assessment, cover the design,
manufacture and operation of the pressure equip-
ment and contain:
– a general description of the type,
– conceptual design and manufacturing draw-
ings and diagrams of components, sub-assem-
blies, circuits, etc.,
Page 22 PED, 02.1998 edition
– descriptions and explanations necessary for an
understanding of the said drawings and dia-
grams and the operation of the pressure equip-
ment,
– a list of the standards referred to in Article 5, ap-
plied in full or in part, and descriptions of the
solutions adopted to meet the essential require-
ments of the Directive where the standards
referred to in Article 5 have not been applied,
– results of design calculations made, examina-
tions carried out, etc.,
– test reports,
– information concerning the tests provided for in
manufacture,
– information concerning the qualifications or ap-
provals required under Sections 3.1.2 and
3.1.3 of Annex I.
4. The notified body must:
4.1. examine the technical documentation, verify that
the type has been manufactured in conformity with
it and identify the components designed in accord-
ance with the relevant provisions of the standards
referred to in Article 5, as well as those designed
without applying the provisions of those standards.
In particular, the notified body must:
– examine the technical documentation with re-
spect to the design and the manufacturing pro-
cedures,
– assess the materials used where these are not
in conformity with the relevant harmonized
standards or with a European approval for
pressure equipment materials, and check the
certificate issued by the material manufacturer
in accordance with Section 4.3 of Annex I,
– approve the procedures for the permanent join-
ing of pressure equipment parts, or check that
they have been previously approved in accord-
ance with Section 3.1.2 of Annex I,
– verify that the personnel undertaking the per-
manent joining of pressure equipment parts
and the non-destructive tests are qualified or
approved in accordance with Sections 3.1.2 or
3.1.3 of Annex I.
4.2. perform or have performed the appropriate exami-
nations and necessary tests to establish whether
the solutions adopted by the manufacturer meet
the essential requirements of the Directive where
the standards referred to in Article 5 have not been
applied.
4.3. perform or have performed the appropriate exami-
nations and necessary tests to establish whether,
where the manufacturer has chosen to apply the
relevant standards, these have actually been ap-
plied.
4.4. agree with the applicant the location where the ex-
aminations and necessary tests are to be carried
out.
5. Where the type satisfies the provisions of the Di-
rective which apply to it, the notified body must is-
sue an EC type-examination certificate to the
applicant. The certificate, which should be valid for
ten years and be renewable, must contain the
name and address of the manufacturer, the con-
clusions of the examination and the necessary
data for identification of the approved type.
A list of the relevant parts of the technical docu-
mentation must be annexed to the certificate and a
copy kept by the notified body.
If the notified body refuses to issue an EC type-ex-
amination certificate to the manufacturer or to his
authorized representative established within the
Community, that body must provide detailed rea-
sons for such refusal. Provision must be made for
an appeals procedure.
6. The applicant must inform the notified body that
holds the technical documentation concerning the
EC type-examination certificate of all modifications
to the approved pressure equipment; these are
subject to additional approval where they may af-
fect conformity with the essential requirements or
the prescribed conditions for use of the pressure
equipment. This additional approval must be given
in the form of an addition to the original EC type-
examination certificate.
7. Each notified body must communicate to the Mem-
ber States the relevant information concerning EC
type-examination certificates which it has with-
drawn, and, on request, those it has issued.
Each notified body must also communicate to the
other notified bodies the relevant information con-
cerning the EC type-examination certificates it has
withdrawn or refused.
8. The other notified bodies may receive copies of the
EC type-examination certificates and/or their addi-
tions. The annexes to the certificates must be held
at the disposal of the other notified bodies.
9. The manufacturer, or his authorized representa-
tive established within the Community, must keep
with the technical documentation copies of EC
type-examination certificates and their additions
for a period of ten years after the last of the pres-
sure equipment has been manufactured.
Where neither the manufacturer nor his authorized
representative is established within the Communi-
ty, the obligation to keep the technical documenta-
tion available is the responsibility of the person
who places the product on the Community market.
Module B1 (EC design-examination)
1. This module describes the part of the procedure
whereby a notified body ascertains and attests that
the design of an item of pressure equipment meets
the provisions of the Directive which apply to it.
The experimental design method provided for in
Section 2.2.4 of Annex I may not be used in the
context of this module.
2. The manufacturer, or his authorized representa-
tive established within the Community, must lodge
an application for EC design examination with a
single notified body.
The application must include:
– the name and address of the manufacturer and,
if the application is lodged by the authorized rep-
resentative, his name and address as well,
– a written declaration that the same application
has not been lodged with any other notified
body,
– the technical documentation described in Sec-
tion 3.
The application may cover several versions of the
pressure equipment provided that the differences
between the versions do not affect the level of
safety.

3. The technical documentation must enable an as-
sessment to be made of the conformity of the pres-
sure equipment with the requirements of the
Directive which apply to it. It must, as far as is rel-
evant for such assessment, cover the design,
manufacture and operation of the pressure equip-
ment and contain:
– a general description of the pressure equip-
ment,
– conceptual design and manufacturing draw-
ings and diagrams of components, sub-assem-
blies, circuits, etc.,
– descriptions and explanations necessary for an
understanding of the said drawings and dia-
grams and the operation of the pressure equip-
ment,
– a list of the standards referred to in Article 5, ap-
plied in full or in part, and descriptions of the
solutions adopted to meet the essential require-
ments of the Directive where the standards re-
ferred to in Article 5 have not been applied,
– the necessary supporting evidence for the ad-
equacy of the design solution, in particular
where the standards referred to in Article 5
have not been applied in full; this supporting
evidence must include the results of tests car-
ried out by the appropriate laboratory of the
manufacturer or on his behalf,
– results of design calculations made, examina-
tions carried out, etc.,
– information regarding the qualifications or ap-
provals required under Sections 3.1.2 and
3.1.3 of Annex I.
4. The notified body must:
4.1. examine the technical documentation and identify
the components which have been designed in ac-
cordance with the relevant provisions of the stand-
ards referred to in Article 5, as well as those which
have been designed without applying the relevant
provisions of those standards.
In particular, the notified body must:
– assess the materials where these are not in
conformity with the relevant harmonized stand-
ards or with a European approval for pressure
equipment materials,
– approve the procedures for the permanent join-
ing of pressure equipment parts, or check that
they have been previously approved in accord-
ance with Section 3.1.2 of Annex I,
– verify that the personnel undertaking the per-
manent joining of pressure equipment parts
and the non-destructive tests are qualified or
approved in accordance with Sections 3.1.2
and 3.1.3 of Annex I.
4.2. perform the necessary examinations to establish
whether the solutions adopted by the manufactur-
er meet the essential requirements of the Directive
where the standards referred to in Article 5 have
not been applied.
4.3. perform the necessary examinations to establish
whether, where the manufacturer has chosen to
apply the relevant standards, these have actually
been applied.
5. Where the design meets the provisions of the Direc-
tive which apply to it, the notified body must issue an
EC design-examination certificate to the applicant.
PED, 02.1998 edition Page 23
The certificate must contain the name and address
of the applicant, the conclusions of the examination,
conditions for its validity and the necessary data for
identification of the approved design.
A list of the relevant parts of the technical docu-
mentation must be annexed to the certificate and a
copy kept by the notified body.
If the notified body refuses to issue an EC design-
examination certificate to the manufacturer or to
his authorized representative established within
the Community, that body must provide detailed
reasons for such refusal. Provision must be made
for an appeals procedure.
6. The applicant must inform the notified body that
holds the technical documentation concerning the
EC design-examination certificate of all modifica-
tions to the approved design; these are subject to
additional approval where such changes may af-
fect the conformity of the pressure equipment with
the essential requirements of the Directive or the
prescribed conditions for use of the equipment.
This additional approval must be given in the form
of an addition to the original EC design-examina-
tion certificate.
7. Each notified body must communicate to the Mem-
ber States the relevant information concerning EC
design-examination certificates which it has with-
drawn, and, on request, those it has issued.
Each notified body must also communicate to the
other notified bodies the relevant information
concerning the EC design-examination certificates
it has withdrawn or refused.
8. The other notified bodies may on request obtain
the relevant information concerning:
– the EC design-examination certificates and ad-
ditions granted,
– the EC design-examination certificates and ad-
ditions withdrawn.
9. The manufacturer, or his authorized representative
established within the Community, must keep with
the technical documentation referred to in Section 3
copies of EC design-examination certificates and
their additions for a period of ten years after the last
of the pressure equipment has been manufactured.
Where neither the manufacturer nor his authorized
representative is established within the Communi-
ty, the obligation to keep the technical documenta-
tion available is the responsibility of the person
who places the product on the Community market.
Module C1 (conformity to type)
1. This module describes that part of the procedure
whereby the manufacturer, or his authorized rep-
resentative established within the Community, en-
sures and declares that pressure equipment is in
conformity with the type as described in the EC
type-examination certificate and satisfies the re-
quirements of the Directive which apply to it. The
manufacturer, or his authorized representative es-
tablished within the Community, must affix the CE
marking to each item of pressure equipment and
draw up a written declaration of conformity.
2. The manufacturer must take all measures neces-
sary to ensure that the manufacturing process re-
quires the manufactured pressure equipment to
comply with the type as described in the EC type-
examination certificate and with the requirements
of the Directive which apply to it.
Page 24 PED, 02.1998 edition
3. The manufacturer, or his authorized representa-
tive established within the Community, must keep
a copy of the declaration of conformity for a period
of ten years after the last of the pressure equip-
ment has been manufactured.
Where neither the manufacturer nor his authorized
representative is established within the Community,
the obligation to keep the technical documentation
available is the responsibility of the person who
places the pressure equipment on the Community
market.
4. Final assessment must be subject to monitoring in
the form of unexpected visits by a notified body
chosen by the manufacturer.
During such visits, the notified body must:
– establish that the manufacturer actually per-
forms final assessment in accordance with
Section 3.2 of Annex I,
– take samples of pressure equipment at the
manufacturing or storage premises in order to
conduct checks. The notified body must as-
sess the number of items of equipment to sam-
ple and whether it is necessary to perform, or
have performed, all or part of final assessment
on the pressure equipment samples.
Should one or more of the items of pressure equip-
ment not conform, the notified body must take ap-
propriate measures.
On the responsibility of the notified body, the man-
ufacturer must affix the former’s identification
number on each item of pressure equipment.
Module D (production quality assurance)
1. This module describes the procedure whereby the
manufacturer who satisfies the obligations of Sec-
tion 2 ensures and declares that the pressure
equipment concerned is in conformity with the type
described in the EC type-examination certificate or
EC design-examination certificate and satisfies the
requirements of the Directive which apply to it. The
manufacturer, or his authorized representative es-
tablished within the Community, must affix the CE
marking to each item of pressure equipment and
draw up a written declaration of conformity. The
CE marking must be accompanied by the identifi-
cation number of the notified body responsible for
surveillance as specified in Section 4.
2. The manufacturer must operate an approved qual-
ity system for production, final inspection and test-
ing as specified in Section 3 and be subject to
surveillance as specified in Section 4.
3. Quality system
3.1. The manufacturer must lodge an application for
assessment of his quality system with a notified
body of his choice.
The application must include:
– all relevant information on the pressure equip-
ment concerned,
– the documentation concerning the quality sys-
tem,
– the technical documentation for the approved
type and a copy of the EC type-examination cer-
tificate or EC design-examination certificate.
3.2. The quality system must ensure compliance of the
pressure equipment with the type described in the
EC type-examination certificate or EC design-ex-
amination certificate and with the requirements of
the Directive which apply to it.
All the elements, requirements and provisions
adopted by the manufacturer must be documented
in a systematic and orderly manner in the form of
written policies, procedures and instructions. This
quality system documentation must permit a con-
sistent interpretation of the quality programmes,
plans, manuals and records.
It must contain in particular an adequate descrip-
tion of:
– the quality objectives and the organizational
structure, responsibilities and powers of the
management with regard to the quality of the
pressure equipment,
– the manufacturing, quality control and quality
assurance techniques, processes and system-
atic measures that will be used, particularly the
procedures used for the permanent joining of
parts as approved in accordance with Section
3.1.2 of Annex I,
– the examinations and tests that will be carried
out before, during and after manufacture, and
the frequency with which they will be carried
out,
– the quality records, such as inspection reports
and test data, calibration data, reports con-
cerning the qualifications or approvals of the
personnel concerned, particularly those of the
personnel undertaking the joining of parts and
the non-destructive tests in accordance with
Sections 3.1.2 and 3.1.3 of Annex I,
– the means of monitoring the achievement of
the required quality and the effective operation
of the quality system.
3.3. The notified body must assess the quality system
to determine whether it satisfies the requirements
referred to in 3.2.The elements of the quality sys-
tem which conform to the relevant harmonized
standard are presumed to comply with the corre-
sponding requirements referred to in 3.2.
The auditing team must have at least one member
with experience of assessing the pressure equip-
ment technology concerned. The assessment pro-
cedure must include an inspection visit to the
manufacturer’s premises.
The decision must be notified to the manufacturer.
The notification must contain the conclusions of
the examination and the reasoned assessment de-
cision. Provision must be made for an appeals pro-
cedure.
3.4. The manufacturer must undertake to fulfil the obli-
gations arising out of the quality system as ap-
proved and to ensure that it remains satisfactory
and efficient.
The manufacturer, or his authorized representa-
tive established within the Community, must in-
form the notified body that has approved the
quality system of any intended adjustment to the
quality system.
The notified body must assess the proposed
changes and decide whether the amended quality
system will still satisfy the requirements referred to
in 3.2 or whether a reassessment is required.
It must notify its decision to the manufacturer.
The notification must contain the conclusions of
the examination and the reasoned assessment
decision.

4. Surveillance under the responsibility of the notified
body
4.1. The purpose of surveillance is to make sure that
the manufacturer duly fulfils the obligations arising
out of the approved quality system.
4.2. The manufacturer must allow the notified body
access for inspection purposes to the locations
of manufacture, inspection, testing and storage
and provide it with all necessary information, in
particular:
– the quality system documentation,
– the quality records, such as inspection reports
and test data, calibration data, reports con-
cerning the qualifications of the personnel con-
cerned, etc.
4.3. The notified body must carry out periodic audits to
make sure that the manufacturer maintains and
applies the quality system and provide the manu-
facturer with an audit report. The frequency of pe-
riodic audits must be such that a full reassessment
is carried out every three years.
4.4. In addition the notified body may pay unexpected
visits to the manufacturer. The need for such addi-
tional visits, and the frequency thereof, will be deter-
mined on the basis of a visit control system
operated by the notified body. In particular, the fol-
lowing factors must be considered in the visit control
system:
– the category of the equipment,
– the results of previous surveillance visits,
– the need to follow up corrective action,
– special conditions linked to the approval of the
system, where applicable,
– significant changes in manufacturing organiza-
tion, policy or techniques.
During such visits the notified body may, if neces-
sary, carry out or have carried out tests to verify
that the quality system is functioning correctly. The
notified body must provide the manufacturer with a
visit report and, if a test has taken place, with a test
report.
5. The manufacturer must, for a period of ten years
after the last of the pressure equipment has been
manufactured, hold at the disposal of the national
authorities:
– the documentation referred to in the second in-
dent of 3.1;
– the adjustments referred to in the second para-
graph of 3.4;
– the decisions and reports from the notified
body which are referred to in the last paragraph
of 3.3, the last paragraph of 3.4, and in 4.3 and
4.4.
6. Each notified body must communicate to the Mem-
ber States the relevant information concerning the
quality system approvals which it has withdrawn,
and, on request, those it has issued.
Each notified body must also communicate to the
other notified bodies the relevant information
concerning the quality system approvals it has
withdrawn or refused.
Module D1 (production quality assurance)
1. This module describes the procedure whereby the
manufacturer who satisfies the obligations of Sec-
tion 3 ensures and declares that the items of pres-
sure equipment concerned satisfy the requirements
PED, 02.1998 edition Page 25
of the Directive which apply to them. The manufac-
turer, or his authorized representative established
within the Community, must affix the CE marking
to each item of pressure equipment and draw up a
written declaration of conformity. The CE marking
must be accompanied by the identification number
of the notified body responsible for surveillance as
specified in Section 5.
2. The manufacturer must draw up the technical
documentation described below.
The technical documentation must enable an as-
sessment to be made of the conformity of the pres-
sure equipment with the requirements of the
Directive which apply to it. It must, as far as is rel-
evant for such assessment, cover the design,
manufacture and operation of the pressure equip-
ment and contain:
– a general description of the pressure equip-
ment,
– conceptual design and manufacturing draw-
ings and diagrams of components, sub-assem-
blies, circuits, etc.,
– descriptions and explanations necessary for an
understanding of the said drawings and dia-
grams and the operation of the pressure equip-
ment,
– a list of the standards referred to in Article 5,
applied in full or in part, and descriptions of the
solutions adopted to meet the essential re-
quirements of the Directive where the stand-
ards referred to in Article 5 have not been
applied,
– results of design calculations made, examina-
tions carried out, etc.,
– test reports.
3. The manufacturer must operate an approved qual-
ity system for production, final inspection and test-
ing as specified in Section 4 and be subject to
surveillance as specified in Section 5.
4. Quality system
4.1. The manufacturer must lodge an application for
assessment of his quality system with a notified
body of his choice.
The application must include:
– all relevant information on the pressure equip-
ment concerned,
– the documentation concerning the quality sys-
tem.
4.2. The quality system must ensure compliance of the
pressure equipment with the requirements of the
Directive which apply to it.
All the elements, requirements and provisions
adopted by the manufacturer must be documented
in a systematic and orderly manner in the form of
written policies, procedures and instructions. This
quality system documentation must permit a con-
sistent interpretation of the quality programmes,
plans, manuals and records.
It must contain in particular an adequate descrip-
tion of:
– the quality objectives and the organizational
structure, responsibilities and powers of the
management with regard to the quality of the
pressure equipment,
– the manufacturing, quality control and quality
assurance techniques, processes and system-
atic measures that will be used, particularly the
Page 26 PED, 02.1998 edition
procedures used for the permanent joining of
parts as approved in accordance with Section
3.1.2 of Annex I,
– the examinations and tests that will be carried
out before, during and after manufacture, and
the frequency with which they will be carried
out,
– the quality records, such as inspection reports
and test data, calibration data, reports con-
cerning the qualifications or approvals of the
personnel concerned, particularly those of the
personnel undertaking the permanent joining
of parts in accordance with Section 3.1.2 of
Annex I,
– the means of monitoring the achievement of
the required quality and the effective operation
of the quality system.
4.3. The notified body must assess the quality system
to determine whether it satisfies the requirements
referred to in 4.2.The elements of the quality sys-
tem which conform to the relevant harmonized
standard are presumed to comply with the corre-
sponding requirements referred to in 4.2.
The auditing team must have at least one member
with experience of assessing the pressure equip-
ment technology concerned. The assessment pro-
cedure must include an inspection visit to the
manufacturer’s premises.
The decision must be notified to the manufacturer.
The notification must contain the conclusions of
the examination and the reasoned assessment de-
cision. Provision must be made for an appeals pro-
cedure.
4.4. The manufacturer must undertake to fulfil the obli-
gations arising out of the quality system as ap-
proved and to ensure that it remains satisfactory
and efficient.
The manufacturer, or his authorized representative
established within the Community, must inform the
notified body that has approved the quality system
of any intended adjustment to the quality system.
The notified body must assess the proposed
changes and decide whether the amended quality
system will still satisfy the requirements referred to
in 4.2 or whether a reassessment is required.
If must notify its decision to the manufacturer. The
notification must contain the conclusions of the ex-
amination and the reasoned assessment decision.
5. Surveillance under the responsibility of the notified
body
5.1. The purpose of surveillance is to make sure that
the manufacturer duly fulfils the obligations arising
out of the approved quality system.
5.2. The manufacturer must allow the notified body ac-
cess for inspection purposes to the locations of
manufacture, inspection, testing and storage and
provide it with all necessary information, in particu-
lar:
– the quality system documentation,
– the quality records, such as inspection reports
and test data, calibration data, reports con-
cerning the qualifications of the personnel con-
cerned, etc.
5.3. The notified body must carry out periodic audits to
make sure that the manufacturer maintains and
applies the quality system and provide the manu-
facturer with an audit report. The frequency of pe-
riodic audits must be such that a full reassessment
is carried out every three years.
5.4. In addition the notified body may pay unexpected
visits to the manufacturer. The need for such addi-
tional visits, and the frequency thereof, will be de-
termined on the basis of a visit control system
operated by the notified body. In particular, the fol-
lowing factors must be considered in the visit con-
trol system:
– the category of the equipment,
– the results of previous surveillance visits,
– the need to follow up corrective action,
– special conditions linked to the approval of the
system, where applicable,
– significant changes in manufacturing organiza-
tion, policy or techniques.
During such visits the notified body may, if neces-
sary, carry out or have carried out tests to verify
that the quality system is functioning correctly. The
notified body must provide the manufacturer with a
visit report and, if a test has taken place, with a test
report.
6. The manufacturer must, for a period of ten years
after the last of the pressure equipment has been
manufactured, hold at the disposal of the national
authorities:
– the technical documentation referred to in Sec-
tion 2,
– the documention referred to in the second in-
dent of 4.1,
– the adjustments referred to in the second par-
agraph of 4.4,
– the decisions and reports from the notified
body which are referred to in the last paragraph
of 4.3, the last paragraph of 4.4, and in 5.3 and
5.4.
7. Each notified body must communicate to the Mem-
ber States the relevant information concerning the
quality system approvals which it has withdrawn,
and, on request, those it has issued.
Each notified body must also communicate to the
other notified bodies the relevant information con-
cerning the quality system approvals it has with-
drawn or refused.
Module E (product quality assurance)
1. This module describes the procedure whereby the
manufacturer who satisfies the obligations of
Section 2 ensures and declares that the pressure
equipment is in conformity with the type as de-
scribed in the EC type-examination certificate and
satisfies the requirements of the Directive which
apply to it. The manufacturer, or his authorized
representative established within the Community,
must affix the CE marking to each product and
draw up a written declaration of conformity. The
CE marking must be accompanied by the identifi-
cation number of the notified body responsible for
surveillance as specified in Section 4.
2. The manufacturer must operate an approved qual-
ity system for the final pressure equipment inspec-
tion and testing as specified in Section 3 and be
subject to surveillance as specified in Section 4.
3. Quality system
3.1. The manufacturer must lodge an application for
assessment of his quality system for the pressure
equipment with a notified body of his choice.

The application must include:
– all relevant information on the pressure equip-
ment concerned,
– the documentation concerning the quality sys-
tem,
– the technical documentation for the approved
type and a copy of the EC type-examination
certificate.
3.2. Under the quality system, each item of pressure
equipment must be examined and appropriate
tests as set out in the relevant standard(s) referred
to in Article 5, or equivalent tests, particularly final
assessment as referred to in Section 3.2 of
Annex I, must be carried out in order to ensure its
conformity with the requirements of the Directive
which apply to it. All the elements, requirements
and provisions adopted by the manufacturer must
be documented in a systematic and orderly man-
ner in the form of written policies, procedures and
instructions. This quality system documentation
must permit a consistent interpretation of the qual-
ity programmes, plans, manuals and records.
It must contain in particular an adequate descrip-
tion of:
– the quality objectives and the organizational
structure, responsibilities and powers of the
management with regard to the quality of the
pressure equipment,
– the examinations and tests to be carried out af-
ter manufacture,
– the means of monitoring the effective operation
of the quality system,
– the quality records, such as inspection reports
and test data, calibration data, reports con-
cerning the qualifications or approvals of the
personnel concerned, particularly those of the
personnel undertaking the permanent joining
of parts and the non-destructive tests in ac-
cordance with Sections 3.1.2 and 3.1.3 of
Annex I.
3.3. The notified body must assess the quality system to
determine whether it satisfies the requirements
referred to in 3.2. The elements of the quality system
which conform to the relevant harmonized standard
are presumed to comply with the corresponding re-
quirements referred to in 3.2.
The auditing team must have at least one member
with experience of assessing the pressure equip-
ment technology concerned. The assessment pro-
cedure must include an inspection visit to the
manufacturer’s premises.
The decision must be notified to the manufacturer.
The notification must contain the conclusions of
the examination and the reasoned assessment de-
cision.
3.4. The manufacturer must undertake to discharge the
obligations arising from the quality system as
approved and to ensure that it remains satisfactory
and efficient.
The manufacturer, or his authorized representa-
tive established within the Community, must in-
form the notified body which has approved the
quality system of any intended adjustment to the
quality system.
The notified body must assess the proposed
changes and decide whether the modified quality
system will still satisfy the requirements referred to
PED, 02.1998 edition Page 27
in 3.2 or whether a reassessment is required.
It must notify its decision to the manufacturer. The
notification must contain the conclusions of the ex-
amination and the reasoned assessment decision.
4. Surveillance under the responsibility of the notified
body
4.1. The purpose of surveillance is to make sure that
the manufacturer duly fulfils the obligations arising
out of the approved quality system.
4.2. The manufacturer must allow the notified body ac-
cess for inspection purposes to the locations of in-
spection, testing and storage and provide it with all
necessary information, in particular:
– the quality system documentation,
– the technical documentation,
– the quality records, such as inspection reports
and test data, calibration data, reports con-
cerning the qualifications of the personnel con-
cerned, etc.
4.3. The notified body must carry out periodic audits to
make sure that the manufacturer maintains and
applies the quality system and provide the manu-
facturer with an audit report. The frequency of pe-
riodic audits must be such that a full reassessment
is carried out every three years.
4.4. In addition the notified body may pay unexpected
visits to the manufacturer. The need for such addi-
tional visits, and the frequency thereof, will be de-
termined on the basis of a visit control system
operated by the notified body. In particular, the fol-
lowing factors must be considered in the visit con-
trol system:
– the category of the equipment,
– the results of previous surveillance visits,
– the need to follow up corrective action,
– special conditions linked to the approval of the
system, where applicable,
– significant changes in manufacturing organiza-
tion, policy or techniques.
During such visits, the notified body may, if neces-
sary, carry out or have carried out tests to verify
that the quality system is functioning correctly. The
notified body must provide the manufacturer with a
visit report and, if a test has taken place, with a test
report.
5. The manufacturer must, for a period of ten years
after the last of the pressure equipment has been
manufactured, hold at the disposal of the national
authorities:
– the documentation referred to in the second in-
dent of 3.1,
– the adjustments referred to in the second par-
agraph of 3.4,
– the decisions and reports from the notified
body which are referred to in the last paragraph
of 3.3, the last paragraph of 3.4, and in 4.3 and
4.4.
6. Each notified body must communicate to the Mem-
ber States the relevant information concerning the
quality system approvals which it has withdrawn
and, on request, those it has issued.
Each notified body must also communicate to the
other notified bodies the relevant information con-
cerning the quality system approvals it has with-
drawn or refused.
Page 28 PED, 02.1998 edition
Module E1 (product quality assurance)
1. This module describes the procedure whereby the
manufacturer who satisfies the obligations of Sec-
tion 3 ensures and declares that the pressure
equipment satisfies the requirements of the Direc-
tive which apply to it. The manufacturer, or his au-
thorized representative established within the
Community, must affix the CE marking to each
item of pressure equipment and draw up a written
declaration of conformity. The CE marking must be
accompanied by the identification number of the
notified body responsible for surveillance as spec-
ified in Section 5.
2. The manufacturer must draw up the technical
documentation described below.
The technical documentation must enable an as-
sessment to be made of the conformity of the pres-
sure equipment with the requirements of the
Directive which apply to it. It must, as far as is rel-
evant for such assessment, cover the design,
manufacture and operation of the pressure equip-
ment and contain:
– a general description of the pressure equip-
ment,
– conceptual design and manufacturing draw-
ings and diagrams of components, sub-assem-
blies, circuits, etc.,
– descriptions and explanations necessary for an
understanding of the said drawings and dia-
grams and the operation of the pressure equip-
ment,
– a list of the standards referred to in Article 5,
applied in full or in part, and descriptions of the
solutions adopted to meet the essential re-
quirements of the Directive where the stand-
ards referred to in Article 5 have not been
applied,
– results of design calculations made, examina-
tions carried out, etc.,
– test reports.
3. The manufacturer must operate an approved qual-
ity system for the final pressure equipment inspec-
tion and testing as specified in Section 4 and be
subject to surveillance as specified in Section 5.
4. Quality system
4.1. The manufacturer must lodge an application for
assessment of his quality system with a notified
body of his choice.
The application must include:
– all relevant information on the pressure equip-
ment concerned,
– the documentation concerning the quality sys-
tem.
4.2. Under the quality system, each item of pressure
equipment must be examined and appropriate
tests as set out in the relevant standard(s) referred
to in Article 5, or equivalent tests, and particularly
final assessment as referred to in Section 3.2 of
Annex I, must be carried out in order to ensure its
conformity with the requirements of the Directive
which apply to it. All the elements, requirements
and provisions adopted by the manufacturer must
be documented in a systematic and orderly man-
ner in the form of written policies, procedures and
instructions. This quality system documentation
must permit a consistent interpretation of the qual-
ity programmes, plans, manuals and records.
It must contain in particular an adequate descrip-
tion of:
– the quality objectives and the organizational
structure, responsibilities and powers of the
management with regard to the quality of the
pressure equipment,
– the procedures used for the permanent joining
of parts as approved in accordance with Sec-
tion 3.1.2 of Annex I,
– the examinations and tests to be carried out af-
ter manufacture,
– the means of monitoring the effective operation
of the quality system,
– the quality records, such as inspection reports
and test data, calibration data, reports con-
cerning the qualifications or approvals of the
personnel concerned, particularly those of the
personnel undertaking the permanent joining
of parts in accordance with Section 3.1.2 of
Annex I.
4.3. The notified body must assess the quality system
to determine whether it satisfies the requirements
referred to in 4.2. The elements of the quality sys-
tem which conform to the relevant harmonized
standard are presumed to comply with the corre-
sponding requirements referred to in 4.2.
The auditing team must have at least one member
with experience of assessing the pressure equip-
ment technology concerned. The assessment pro-
cedure must include an inspection visit to the
manufacturer’s premises.
The decision must be notified to the manufacturer.
The notification must contain the conclusions of
the examination and the reasoned assessment de-
cision. Provision must be made for an appeals pro-
cedure.
4.4. The manufacturer must undertake to discharge the
obligations arising from the quality system as ap-
proved and to ensure that it remains satisfactory
and efficient.
The manufacturer, or his authorized representa-
tive established within the Community, must in-
form the notified body which has approved the
quality system of any intended adjustment to the
quality system.
The notified body must assess the proposed
changes and decide whether the modified quality
system will still satisfy the requirements referred to
in 4.2 or whether a reassessment is required.
It must notify its decision to the manufacturer. The
notification must contain the conclusions of the ex-
amination and the reasoned assessment decision.
5. Surveillance under the responsibility of the notified
body
5.1. The purpose of surveillance is to make sure that
the manufacturer duly fulfils the obligations arising
out of the approved quality system.
5.2. The manufacturer must allow the notified body ac-
cess for inspection purposes to the locations of in-
spection, testing and storage and provide it with all
necessary information, in particular:
– the quality system documentation,
– the technical documentation,
– the quality records, such as inspection reports
and test data, calibration data, reports con-
cerning the qualifications of the personnel con-
cerned, etc.

5.3. The notified body must carry out periodic audits to
make sure that the manufacturer maintains and
applies the quality system and provide the manu-
facturer with an audit report. The frequency of pe-
riodic audits must be such that a full reassessment
is carried out every three years.
5.4. In addition the notified body may pay unexpected
visits to the manufacturer. The need for such addi-
tional visits, and the frequency thereof, will be de-
termined on the basis of a visit control system
operated by the notified body. In particular, the fol-
lowing factors must be considered in the visit con-
trol system:
– the category of the equipment,
– the results of previous surveillance visits,
– the need to follow up corrective action,
– special conditions linked to the approval of the
system, where applicable,
– significant changes in manufacturing organiza-
tion, policy or techniques.
During such visits the notified body may, if neces-
sary, carry out or have carried out tests to verify
that the quality system is functioning correctly. The
notified body must provide the manufacturer with a
visit report and, if a test has taken place, with a test
report.
6. The manufacturer must, for a period of ten years
after the last of the pressure equipment has been
manufactured, keep at the disposal of the national
authorities:
– the technical documentation referred to in Sec-
tion 2,
– the documentation referred to in the second in-
dent of 4.1,
– the adjustments referred to in the second par-
agraph of 4.4,
– the decisions and reports from the notified body
which are referred to in the last paragraph of 4.3,
the last paragraph of 4.4 and in 5.3 and 5.4.
7. Each notified body must communicate to the Mem-
ber States the relevant information concerning the
quality system approvals which it has withdrawn
and, on request, those is has issued.
Each notified body must also communicate to the
other notified bodies the relevant information con-
cerning the quality system approvals it has with-
drawn or refused.
Module F (product verification)
1. This module describes the procedure whereby a
manufacturer, or his authorized representative es-
tablished within the Community, ensures and de-
clares that the pressure equipment subject to the
provisions of Section 3 is in conformity with the
type described:
– in the EC type-examination certificate, or
– in the EC design-examination certificate
and satisfies the requirements of the Directive
which apply to it.
2. The manufacturer must take all measures neces-
sary to ensure that the manufacturing process re-
quires the pressure equipment to comply with the
type described
– in the EC type-examination certificate, or
– in the EC design-examination certificate
and with the requirements of the Directive which
apply to it.
PED, 02.1998 edition Page 29
The manufacturer, or his authorized representa-
tive established within the Community, must affix
the CE marking to all pressure equipment and
draw up a declaration of conformity.
3. The notified body must perform the appropriate ex-
aminations and tests in order to check the conform-
ity of the pressure equipment with the relevant
requirements of the Directive by examining and test-
ing every product in accordance with Section 4.
The manufacturer, or his authorized representa-
tive established within the Community, must keep
a copy of the declaration of conformity for a period
of ten years after the last of the pressure equip-
ment has been manufactured.
4. Verification by examination and testing of each
item of pressure equipment
4.1. Each item of pressure equipment must be individ-
ually examined and must undergo appropriate ex-
aminations and tests as set out in the relevant
standard(s) referred to in Article 5 or equivalent ex-
aminations and tests in order to verify that it con-
forms to the type and the requirements of the
Directive which apply to it.
In particular, the notified body must:
– verify that the personnel undertaking the per-
manent joining of parts and the non-destructive
tests are qualified or approved in accordance
with Sections 3.1.2 and 3.1.3 of Annex I,
– verify the certificate issued by the materials
manufacturer in accordance with Section 4.3 of
Annex I,
– carry out or have carried out the final inspection
and proof test referred to in Section 3.2 of
Annex I and examine the safety devices, if appli-
cable.
4.2. The notified body must affix its identification
number or have it affixed to each item of pressure
equipment and draw up a written certificate of con-
formity relating to the tests carried out.
4.3. The manufacturer, or his authorized representative
established within the Community, must ensure that
the certificates of conformity issued by the notified
body can be made available on request.
Module G (EC unit verification)
1. This module describes the procedure whereby the
manufacturer ensures and declares that pressure
equipment which has been issued with the certifi-
cate referred to in Section 4.1 satisfies the require-
ments of the Directive which apply to it. The manu-
facturer must affix the CE marking to the pressure
equipment and draw up a declaration of conformity.
2. The manufacturer must apply to a notified body of
his choice for unit verification.
The application must contain:
– the name and address of the manufacturer and
the location of the pressure equipment,
– a written declaration to the effect that a similar
application has not been lodged with another
notified body,
– technical documentation.
3. The technical documentation must enable the con-
formity of the pressure equipment with the require-
ments of the Directive which apply to it to be
assessed and the design, manufacture and opera-
tion of the pressure equipment to be understood.
Page 30 PED, 02.1998 edition
The technical documentation must contain:
– a general description of the pressure equip-
ment,
– conceptual design and manufacturing draw-
ings and diagrams of components, sub-assem-
blies, circuits, etc.,
– descriptions and explanations necessary for an
understanding of the said drawings and dia-
grams and the operation of the pressure equip-
ment,
– a list of the standards referred to in Article 5,
applied in full or in part, and descriptions of the
solutions adopted to meet the essential re-
quirements of the Directive where the standards
referred to in Article 5 have not been applied,
– results of design calculations made, examina-
tions carried out, etc.,
– test reports,
– appropriate details relating to the approval of
the manufacturing and test procedures and of
the qualifications or approvals of the personnel
concerned in accordance with Sections 3.1.2
and 3.1.3 of Annex I.
4. The notified body must examine the design and
construction of each item of pressure equipment
and during manufacture perform appropriate tests
as set out in the relevant standard(s) referred to in
Article 5 of the Directive, or equivalent examina-
tions and tests, to ensure its conformity with the re-
quirements of the Directive which apply to it.
In particular the notified body must:
– examine the technical documentation with re-
spect to the design and the manufacturing pro-
cedures,
– assess the materials used where these are not
in conformity with the relevant harmonized
standards or with a European approval for
pressure equipment materials, and check the
certificate issued by the material manufacturer
in accordance with Section 4.3 of Annex I,
– approve the procedures for the permanent join-
ing of parts or check that they have been previ-
ously approved in accordance with Section
3.1.2 of Annex I,
– verify the qualifications or approvals required
under Sections 3.1.2 and 3.1.3 of Annex I,
– carry out the final inspection referred to in Sec-
tion 3.2.1 of Annex I, perform or have performed
the proof test referred to in Section 3.2.2 of
Annex I, and examine the safety devices, if ap-
plicable.
4.1. The notified body must affix its identification
number or have it affixed to the pressure equip-
ment and draw up a certificate of conformity for the
tests carried out. This certificate must be kept for a
period of ten years.
4.2. The manufacturer, or his authorized representa-
tive established within the Community, must en-
sure that the declaration of conformity and
certificate of conformity issued by the notified body
can be made available on request.
Module H (full quality assurance)
1. This module describes the procedure whereby the
manufacturer who satisfies the obligations of Sec-
tion 2 ensures and declares that the pressure equip-
ment in question satisfies the requirements of the
Directive which apply to it. The manufacturer, or his
authorized representative established within the
Community, must affix the CE marking to each item
of pressure equipment and draw up a written decla-
ration of conformity. The CE marking must be ac-
companied by the identification number of the
notified body responsible for surveillance as speci-
fied in Section 4.
2. The manufacturer must implement an approved
quality system for design, manufacture, final in-
spection and testing as specified in Section 3 and
be subject to surveillance as specified in Section 4.
3. Quality system
3.1. The manufacturer must lodge an application for
assessment of his quality system with a notified
body of his choice.
The application must include:
– all relevant information concerning the pres-
sure equipment in question,
– the documentation concerning the quality sys-
tem.
3.2. The quality system must ensure compliance of the
pressure equipment with the requirements of the
Directive which apply to it.
All the elements, requirements and provisions
adopted by the manufacturer must be documented
in a systematic and orderly manner in the form of
written policies, procedures and instructions. This
quality system documentation must permit a con-
sistent interpretation of the procedural and quality
measures such as programmes, plans, manuals
and records.
It must contain in particular an adequate descrip-
tion of:
– the quality objectives and the organizational
structure, responsibilities and powers of the
management with regard to the quality of the
design and to product quality,
– the technical design specifications, including
standards, that will be applied and, where the
standards referred to in Article 5 are not ap-
plied in full, the means that will be used to en-
sure that the essential requirements of the
Directive which apply to the pressure equip-
ment will be met,
– the design control and design verification tech-
niques, processes and systematic measures
that will be used when designing the pressure
equipment, particularly with regard to materials
in accordance with Section 4 of Annex I,
– the corresponding manufacturing, quality con-
trol and quality assurance techniques, proc-
esses and systematic measures that will be
used, particularly the procedures for the per-
manent joining of parts as approved in accord-
ance with Section 3.2.2 of Annex I,
– the examinations and tests to be carried out
before, during, and after manufacture, and the
frequency with which they will be carried out,
– the quality records, such as inspection reports
and test data, calibration data, reports con-
cerning the qualifications or approvals of the
personnel concerned, particularly those of the
personnel undertaking the permanent joining
of parts and the non-destructive tests in ac-
cordance with Sections 3.1.2 and 3.1.3 of
Annex I,

– the means of monitoring the achievement of
the required pressure equipment design and
quality and the effective operation of the quality
system.
3.3. The notified body must assess the quality system
to determine whether it satisfies the requirements
referred to in 3.2. The elements of the quality sys-
tem which conform to the relevant harmonized
standard are presumed to comply with the corre-
sponding requirements referred to in 3.2.
The auditing team must have at least one member
with experience of assessing the pressure equip-
ment technology concerned. The assessment pro-
cedure must include an inspection visit to the
manufacturer’s premises.
The decision must be notified to the manufacturer.
The notification must contain the conclusions of
the examination and the reasoned assessment de-
cision. Provision must be made for an appeals pro-
cedure.
3.4. The manufacturer must undertake to fulfil the obli-
gations arising out of the quality system as ap-
proved and to ensure that it remains satisfactory
and efficient.
The manufacturer, or his authorized representative
established within the Community, must inform the
notified body that has approved the quality system
of any intended adjustment to the quality system.
The notified body must assess the proposed
changes and decide whether the modified quality
system will still satisfy the requirements referred to
in 3.2 or whether a reassessment is required.
It must notify its decision to the manufacturer. The
notification must contain the conclusions of the ex-
amination and the reasoned assessment decision.
4. Surveillance under the responsibility of the notified
body
4.1. The purpose of this surveillance is to make sure
that the manufacturer duly fulfils the obligations
arising out of the approved quality system.
4.2. The manufacturer must allow the notified body ac-
cess for inspection purposes to the locations of
design, manufacture, inspection, testing and stor-
age and provide it with all necessary information,
in particular:
– the quality system documentation,
– the quality records provided for in the design
part of the quality system, such as results of
analyses, calculations, tests, etc.,
– the quality records provided for in the manufac-
turing part of the quality system, such as in-
spection reports and test data, calibration data,
reports concerning the qualifications of the per-
sonnel concerned, etc.
4.3. The notified body must carry out periodic audits to
make sure that the manufacturer maintains and
applies the quality system and provide the manu-
facturer with an audit report. The frequency of pe-
riodic audits must be such that a full reassessment
is carried out every three years.
4.4. In addition the notified body may pay unexpected
visits to the manufacturer. The need for such addi-
tional visits, and the frequency thereof, will be de-
termined on the basis of a visit control system
operated by the notified body. In particular, the fol-
lowing factors must be considered in the visit con-
trol system:
PED, 02.1998 edition Page 31
– the category of the equipment,
– the results of previous surveillance visits,
– the need to follow up corrective action,
– special conditions linked to the approval of the
system, where applicable,
– significant changes in manufacturing organiza-
tion, policy or techniques.
During such visits the notified body may, if neces-
sary, carry out or have carried out tests to verify
that the quality system is functioning correctly. The
notified body must provide the manufacturer with a
visit report and, if a test has taken place, with a test
report.
5. The manufacturer must, for a period of ten years
after the last of the pressure equipment has been
manufactured, keep at the disposal of the national
authorities:
– the documentation referred to in the second in-
dent of the second subparagraph of 3.1;
– the adjustments referred to in the second sub-
paragraph of 3.4;
– the decisions and reports from the notified
body which are referred to in the last subpara-
graph of 3.3, the last subparagraph of 3.4, and
in 4.3 and 4.4.
6. Each notified body must communicate to the Mem-
ber States the relevant information concerning the
quality system approvals which it has withdrawn,
and, on request, those it has issued.
Each notified body must also communicate to the
other notified bodies the relevant information con-
cerning the quality system approvals it has with-
drawn or refused.
Module H1 (full quality assurance with design
examination and special surveillance
of the final assessment)
1. In addition to the requirements of module H, the
following apply:
a) the manufacturer must lodge an application for
examination of the design with the notified
body;
b) the application must enable the design, manu-
facture and operation of the pressure equip-
ment to be understood, and enable conformity
with the relevant requirements of the Directive
to be assessed.
It must include:
– the technical design specifications, includ-
ing standards, which have been applied,
– the necessary supporting evidence for their
adequacy, in particular where the stand-
ards referred to in Article 5 have not been
applied in full. This supporting evidence
must include the results of tests carried out
by the appropriate laboratory of the manu-
facturer or on his behalf;
c) the notified body must examine the application
and where the design meets the provisions of
the Directive which apply to it issue an EC de-
sign-examination certificate to the applicant.
The certificate must contain the conclusions of
the examination, the conditions for its validity,
the necessary data for identification of the ap-
proved design and, if relevant, a description of
the functioning of the pressure equipment or
accessories;
Page 32 PED, 02.1998 edition
d) the applicant must inform the notified body that
has issued the EC design-examination certifi-
cate of all modifications to the approved design.
Modifications to the approved design must re-
ceive additional approval from the notified body
that issued the EC design-examination certifi-
cate where they may affect conformity with the
essential requirements of the Directive or the
prescribed conditions for use of the pressure
equipment. This additional approval must be
given in the form of an addition to the original EC
design-examination certificate;
e) each notified body must also communicate to
the other notified bodies the relevant informa-
tion concerning the EC design-examination
certificates it has withdrawn or refused.
2. Final assessment as referred to in Section 3.2 of
Annex I is subject to increased surveillance in the
form of unexpected visits by the notified body. In
the course of such visits, the notified body must
conduct examinations on the pressure equipment.

Annex IV
MINIMUM CRITERIA TO BE MET WHEN DESIGNATING THE NOTIFIED BODIES REFERRED TO IN ARTIKEL 12
AND THE RECOGNIZED THIRD-PARTY ORGANIZATIONS REFERRED TO IN ARTIKEL 13
1. The body, its director and the personnel responsi-
ble for carrying out the assessment and verifica-
tion operations may not be the designer,
manufacturer, supplier, installer or user of the
pressure equipment or assemblies which that
body inspects, nor the authorized representative of
any of those parties. They may not become directly
involved in the design, construction, marketing or
maintenance of the pressure equipment or assem-
blies, nor represent the parties engaged in these
activities. This does not preclude the possibility of
exchanges of technical information between the
manufacturer of pressure equipment or assem-
blies and the notified body.
2. The body and its personnel must carry out the as-
sessments and verifications with the highest degree
of professional integrity and technical competence
and must be free from all pressures and induce-
ments, particularly financial, which might influence
their judgment or the results of the inspection, espe-
cially from persons or groups of persons with an in-
terest in the results of verifications.
3. The body must have at its disposal the necessary
personnel and possess the necessary facilities to
enable it to perform properly the technical and ad-
ministrative tasks connected with the inspection
and surveillance operations, it must also have ac-
PED, 02.1998 edition Page 33
cess to the equipment required to perform special
verifications.
4. The personnel responsible for inspection must
have:
– sound technical and vocational training,
– satisfactory knowledge of the requirements of
the inspections they carry out and adequate
experience of such operations,
– the ability required to draw up the certificates,
records and reports to demonstrate that the in-
spections have been carried out.
5. The impartiality of the inspection personnel must
be guaranteed. Their remuneration must not de-
pend on the number of inspections carried out, nor
on the results of such inspections.
6. The body must take out liability insurance unless
its liability is assumed by the State in accordance
with national law, or the Member State itself is di-
rectly responsible for the inspections.
7. The personnel of the body must observe profes-
sional secrecy with regard to all information gained
in carrying out their tasks (except vis-à-vis the
competent administrative authorities of the State in
which their activities are carried out) under the Di-
rective or any provision of national law giving effect
to it.
Page 34 PED, 02.1998 edition
Annex V
CRITERIA TO BE MET WHEN AUTHORIZING USER INSPECTORATES REFERRED TO IN ARTIKEL 14
1. The user inspectorate must be organizationally
identifiable and have reporting methods within the
group of which it is part which ensure and demon-
strate its impartiality. It must not be responsible for
the design, manufacture, supply, installation, oper-
ation or maintenance of the pressure equipment or
assemblies, and must not engage in any activities
that might conflict with its independence of judg-
ment and integrity in relation to its inspection activi-
ties.
2. The user inspectorate and its personnel must carry
out the assessments and verifications with the
highest degree of professional integrity and techni-
cal competence and must be free from all pres-
sures and inducements, particularly financial,
which might influence their judgment or the results
of the inspection, especially from persons or
groups of persons with an interest in the results of
verifications.
3. The user inspectorate must have at its disposal the
necessary personnel and possess the necessary
facilities to enable it to perform properly the techni-
cal and administrative tasks connected with the in-
spection and surveillance operations; it must also
have access to the equipment required to perform
special verifications.
4. The personnel responsible for inspection must
have:
– sound technical and vocational training,
– satisfactory knowledge of the requirements of
the inspections they carry out and adequate
experience of such operations,
– the ability required to draw up the certificates,
records and reports to demonstrate that the in-
spections have been carried out.
5. The impartiality of inspection personnel must be
guaranteed. Their remuneration must not depend
on the number of inspections carried out, nor on
the results of such inspections.
6. The user inspectorate must have adequate liability
insurance unless liability is assumed by the group
of which it is part.
7. The personnel of the user inspectorate must ob-
serve professional secrecy with regard to all infor-
mation gained in carrying out their tasks (except
vis-à-vis the competent administrative authorities
of the State in which their activities are carried out)
under the Directive or any provision of national law
giving effect to it.
 PED, 02.1998 edition Page 35

Annex VI
CE MARKING

The CE marking consists of the initials “CE” taking the fol-
lowing form:
If the CE marking is reduced or enlarged the proportions giv-
en in the above graduated drawing must be respected.
The various components of the CE marking must have sub-
stantially the same vertical dimension, which may not be
less than 5 mm.
Page 36 PED, 02.1998 edition

Annex VII
DECLARATION OF CONFORMITY

The EC declaration of conformity must contain the following
particulars:
– name and address of the manufacturer or of his authori-
zed representative established within the Community,
– description of the pressure equipment or assembly,
– conformity assessment procedure followed,
– in the case of assemblies, description of the pressure
equipment constituting the assembly, and the conformity
assessment procedures followed,
– where appropriate, name and address of the notified
body which carried out the inspection,
– where appropriate, a reference to the EC type-exami-
nation certificate, EC design-examination certificate or
EC certificate of conformity,
– where appropriate, name and address of the notified
body monitoring the manufacturer’s quality assurance
system,
– where appropriate, the references of the harmonized
standards applied,
– where appropriate, other technical standards and speci-
fications used,
– where appropriate, the references of the other Commu-
nity Directives applied,
– particulars of the signatory authorized to sign the legally
binding declaration for the manufacturer or his authorized
representative established within the Community.